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 .
Status of the Claims
Claims 1-20 are pending and examined herein.
No claims are canceled.
Priority
As detailed on the 16 October 2023 filing receipt, the application claims priority as early as 23 December 2020 to provisional application 63/130,063. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Information Disclosure Statement
Information disclosure statements (IDS) were filed on 11 October 2023 and 04 November 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the references are being considered by the examiner.
Specification
The disclosure is objected to because of the following informality: the equation in paragraph [33] appears to refer to both pW and CD as solid fraction of the droplet.
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because the step “applying” should read “apply” to be consistent with the steps in parent claim 1.
Claim 18 is objected to because the step “cause” should read “causing” to be consistent with the steps in parent claim 11.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is a suitability assessment module which determines median particle size and stability assessment module which identifies one or more predictive quadrative models by fitting response variables to the statistical design, both present in claims 1 and 11. Claims 1 and 11 also recite a device of a user for display.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The claims recite determining a median particle size by suitability assessment. The steps are considered to be carried out in the memory of a computer and thus are interpreted as program. The steps for predicting particle size are disclosed in the specification according to the equation in paragraph [33] relating droplet diameter, particle density, droplet density, and solid fraction of the droplet.
The fitting of variables to the statistical design performed by the stability assessment model is also disclosed in mathematical terms, including an F-test and lack of fit test (pg. 7-8, paragraphs [36-37]).
The recited display device is disclosed as a remote web client or mobile device of a user (pg. 17, paragraph [81]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a computing system for optimizing atomization settings comprising processors and memory. Dependent claim 4 recites a step to make a respirable biopharmaceutical powder and claim 5 recites delivering said powder via nebulizer and/or inhaler. The specification does not disclose how the computing system, interpreted as a general purpose computer (paragraphs [26-27]) can make the designed powder and deliver the powder via an inhaler or nebulizer. Therefore, these claims are considered to lack sufficient written description and are rejected under 35 USC 112(a).
35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements individually and in combination, are directed to a judicial exception at Step 2A, Prong 2, and the additional elements of the claims, considered individually and in combination, do not provide significantly more at Step 2B than the abstract idea of forecasting modeling for optimizing atomization settings.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of
nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The claims are directed to a computer system (claims 1-10) and a method (claims 11-20), each of which falls within one of the categories of statutory subject matter. [Step 1: Yes]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Claims 1 and 11 recite determining a predicted particle size, which, in view of the Claims Interpretation under 35 USC 112(f), is based on a mathematical equation.
Claims 1 and 11 recite identifying models, which is a data evaluation step, based on fitting variables in predictive quadratic formula models, which is a mathematical concept.
Claims 2 and 12 recite applying a desirability function to optimize the models. Under a broadest reasonable interpretation, a function to optimize a mathematical model is also a mathematical concept.
Claims 3, 6, 13, and 16 are directed to data being modeled, where data per se is abstract.
Claims 7 and 17 are parameters of the mathematical model for predicted median particle size and thus are also part of the mathematical concept.
Claims 8 and 18 recite comparing results, where such a comparison is interpreted as data evaluation and judgement and thus a mental process. The “particle processing and analysis system” in claim 8 is not recited as part of the “forecasting modeling computing system” and thus is outside the metes and bounds of the claims. This claim element is therefore interpreted as comparing data generating outside of the system.
Thus, the claims recite abstract ideas and thus must be examined further to determine whether elements in addition to the abstract ideas integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Because the claims recite judicial exceptions, direction under Step 2A Prong Two provides that the claims must be examined further to determine whether they recite elements in addition to the abstract ideas which integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(III)).
Claims 1 and 11 recite a computing system comprising processors and memory. Claim 11 recites a display device. The display device of claim 1 is not recited as part of the forecasting modeling computing system and so is outside the metes and bounds of claim 1.
Claims 1 and 11 recite to receive a user selection and cause a surface response visualization.
Claims 4 and 14 recite to make a respirable biopharmaceutical powder.
Claims 5 and 15 recite to deliver said powder by nebulizer and/or dry powder inhaler.
Claims 8 and 18 recite causing an experiment to be initiated in a particle processing and analysis system.
Claims 9-10 recite receiving data.
Claims 18-20 recite a particle processing and analysis system.
The claims comprising computer components do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than that a generic computer performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Receiving and transmitting data are data gathering and outputting steps, which are considered insignificant extra-solution activity (MPEP 2106.05(g)). The claim elements comprising rendering visualizations, which reads on data outputting, which is insignificant extra-solution activity (MPEP 2106.05(g)).
The claims recite making a respirable biopharmaceutical powder and delivering said powder by nebulizer and/or inhaler. These elements are interpreted as instructions to apply the abstract ideas of the atomization modeling (MPEP 2106.05(f)).
Thus, the claims recite elements in addition to the abstract ideas which do not integrate the abstract ideas into a practical application, and must be examined further to determine whether elements in addition to the abstract ideas provide significantly more (MPEP 2106.05). [Step 2A Prong Two: Yes]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claims 1 and 11 recite a computing system comprising processors and memory.
Claims 1 and 11 recite to receive a user selection and cause a surface response visualization.
Claim 4 recites to make a respirable biopharmaceutical powder.
Claim 5 recites to deliver said powder by nebulizer and/or dry powder inhaler.
Claim 8 recites causing an experiment to be initiated.
Claims 9-10 recite receiving data.
Claims 18-20 recite a particle processing and analysis system, interpreted as system for producing the biopharmaceutical powder.
A review by Shetty (Expert Opinion in Drug Delivery 17(1): 77-96, 2020; newly cited) teaches production of pharmaceutical powder for delivery via inhaler (abstract), wherein the powders are produced by various techniques (Fig. 1).
The claims recite a computer, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions, which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f). Display steps are interpreted as insignificant extra-solution activity (MPEP 2106.05(g)) which do not impose meaningful limits on the claim, here displaying an output of the analysis (Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55; MPEP 2106.05(g)).
The courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93 (storing and retrieving information in memory), as discussed in MPEP 2106.05(d)(II)(i)). Steps reciting transmitting and receiving data are thus conventional.
Therefore, the recited additional elements, alone or in combination, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole,
are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 4-6, 8-12, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrati (AAPS PharmSciTech 19(7): 2755-1766, 2018; previously cited on the 11 October 2023 IDS form) in view of Yas (Iraqi Journal of Pharmaceutical Sciences 22(1): 65-81, 2013; newly cited).
Claim 1 recites to receive a user selection of a plurality of design parameters with respect to a statistical design.
Ferrati teaches processing parameters such as atomization (pg. 2755, col. 2, second paragraph) and size exclusion (pg. 2760, col. 2, third paragraph) as parameters of interest for an aerosol.
Claim 1 recites to determine a predicted median particle size.
Ferrati teaches the median diameter is determined mathematically (pg. 2758, col. 2, last paragraph).
Claim 1 recites to identify one or more predictive quadratic models by fitting each of one or more response variables assessed in a statistical experiment corresponding to the statistical design and for each of the one or more predictive quadratic models, a response surface visualization to be displayed in a display device of a user.
Ferrati does not teach a quadratic model fitting response variables using quadratic models nor a visualization related to the models.
Claim 1 recites system is a computing system comprising processors and memory.
Ferrati teaches the analysis was at least partially performed using software (pg. 1759, col. 1, first paragraph), which requires a general purpose computer comprising a processor and memory.
Yas teaches determining particle formulations in view of quadratic models generated by a design (pg. 66, col. 2, first paragraph) and visualizing response surfaces (Figs. 3-4, 7-9).
Claim 11 recites a method comprising the above steps, which are likewise taught by Ferrati and Yas.
Claims 2 and 12 recite to apply a desirability function to further optimize the predictive quadratic models.
Yas teaches optimization of the preparation using a desirability function (pg. 69, col. 1, second paragraph).
Claims 4 and 14 recite the predictive modeling computing system is used to make a respirable biopharmaceutical powder.
Ferrati teaches developing respirable protein powders (abstract).
Claims 5 and 15 recite to deliver the respirable biopharmaceutical powder via one or both of (i) a nebulizer, and (ii) a dry powder inhaler.
Ferrati teaches delivery through a dry powder inhaler (abstract keywords).
Claim 6 recites the assessed response variables include one or more of: a percent change in the amount of oligomer species, a change in Z-average, a change in secondary structure content, a change in melting endotherm peak, or a predicted median particle size.
Yas teaches MMAD as a response variable, which is median particle size (pg. 70, Table 5).
Claims 8 and 18 recite to cause, in a particle processing and analysis system, a subsequent experiment to be initiated using the predictive quadratic models to control atomization settings; and compare a result of the subsequent experiment to a result of the statistical experiment corresponding to the statistical design.
Yas teaches experimentally confirming the reliability of the response predictions (pg. 69, col. 1, first paragraph), and predicted and experimental values being insignificantly different (pg. 74, col. 2, third paragraph), which is a result comparison.
Claims 9 and 19 recite to receive, from a particle processing and analysis system, experimental data corresponding generated by a particle processing method, the experimental data corresponding to the one or more assessed response variables.
Yas teaches experimental values being valid for predicting dependent response values (pg. 74, col. 2, third paragraph).
Claims 10 and 20 recite to receive, from a particle processing and analysis system, experimental data corresponding generated by a stored particle analysis method, the experimental data corresponding to the one or more assessed response variables.
Yas teaches experimental values being valid for predicting dependent response values (pg. 74, col. 2, third paragraph) which is based on a quadratic equation generated by software and thus stored electronically (pg. 66, col. 1, first paragraph).
Yas teaches experimentally confirming the reliability of the response predictions (pg. 69, col. 1, first paragraph), and predicted and experimental values being insignificantly different (pg. 74, col. 2, third paragraph), which is a result comparison.
Claim 16 recites the statistical design is a Box-Behnken Design of Experiment and the assessed response variables include one or more of: a percent change in the amount of oligomer species, a change in Z-average, a change in secondary structure content, a change in melting endotherm peak, or a predicted median particle size.
Yas teaches a Box-Behnken design of experiments (abstract) including mass median aerodynamic diameter as a response, which is median particle size.
Combining Ferrati and Yas
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would been motivated to combine the works of Ferrati and Yas because Yas teaches the quadratic equations, surface visualizations, and desirability functions not taught by Ferrati. Yas teaches the desirability function is used to determine an optimized formula (pg. 69, col. 1, second paragraph), where an optimization would be a desirable characteristic in determining the inhalation formula of Ferrati. Furthermore, the quadratic models determined by the Box-Behnken design are disclosed by Yas as having important advantages in comparison, cost less time and energy, and avoid experiments in the extremes with undesirable outcomes (pg. 66, col. 2, second paragraph). Both Ferrati and Yas are directed to the shared field of endeavor of developing and delivering biopharmaceutical particles for inhalation, and their combination would be expected to be prima facie obvious.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrati in view of Yas as applied to claims 1-2, 4-6, 8-12, 14-16, and 18-20 above and further in view of Brunaugh (Mol. Pharm 16(10): 4165-4180, 2019; previously cited on the 11 October 2023 IDS form).
Claims 3 and 13 recite the protein is an antibody.
Brunaugh teaches delivery of monoclonal antibodies (pg. 2, first paragraph).
Combining Ferrati, Yas, and Brunaugh
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would been motivated to combine the works of Ferrati and Yas with Brunaugh because Ferrati teaches evaluation of formulation factors and stability of protein powders (pg. 2756, col. 2, first paragraph) and Brunaugh is also directed to formulation and performance of respirable protein powders (abstract), further teaching delivery as a respirable powder is a desirable delivery method for monoclonal antibodies (pg. 2, first paragraph). Therefore, the invention is prima facie obvious.
Subject Matter Free of the Prior Art
Claims 7 and 17 recite the predicted median particle size is determined by analyzing a respective droplet size, a weight fraction, and a dried particle size. Brunaugh, for instance, teaches a relationship between freeze-dried powders and particle size (pg. 3, last paragraph), but the prior art is not considered to teach or fairly suggest the combination of droplet size, a weight fraction, and a dried particle size to predict median particle size.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia M. Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.J.K./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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