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 1-20 are pending and under examination.
Claims 1, 8, 13, and 18 are independent.
Claims 1-20 are rejected.
No claims are allowed, amended, canceled, new, or withdrawn.
Office Action Outline
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 03/03/2023 filing receipt, this application claims priority to as early as 03/23/2022, the filing date of foreign application INDIA 202241016187. At this point in examination, all claims have been interpreted as being accorded this priority date.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 03/03/2023.
Drawings
The drawings are objected to because the drawings do not include numbering of sheets. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking. See MPEP 608.02(V) and 37 C.F.R. 1.84(t) for sheet numbering; MPEP 608.02(V) and 37 C.F.R. 1.84(g) for margins.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim rejections - 112/b
The following is a quotation of 35 USC 112(b):
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 13-17 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
Claim 13 is to a 101 machine or manufacture, i.e. a "system" in this instance, interpreted by statute according to its claimed physical structure, but it is not clear what is the structure associated with the recited "perform..." and similar steps. Therefore, it is not clear whether the claim is limited according to these steps. MPEP 2106.03, 5th-6th paras. pertain. The recited "system" and "processors" are interpreted as not clearly requiring structure linking the "system" to the recited steps in a structural sense appropriate to a claim to a machine or manufacture. PHOSITA may understand these elements to comprise computer processors, but structure should be recited specifically corresponding to the recited, stored software. While these elements may comprise software storage in some embodiments, it is not clear that all embodiments of these elements must comprise software storage corresponding to the recited process steps. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system," and instructions stored therein and configured according to the recited elements and steps. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
Claim Rejections - 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 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people);
• mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information);
• laws of nature and natural phenomena are naturally occurring principles and/or relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 1-7 and 18-20 are directed to a 101 machine or manufacture, here a non-transitory computer-readable medium (CRM). Claims 8-12 are directed to a 101 process, here a method. Claims 13-17 are directed to a 101 machine or manufacture, here a system. As such, claims 1-20 are directed to a related CRM, method, and system which fall under categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 2A, Prong One:
The claims recite judicial exceptions (JEs) of abstract ideas in the form of mental processes and mathematical concepts, as follows:
• generating a single conduit model having conduit generations representing portions of corresponding generations of a lung (claim 1)
• performing a computational fluid dynamics (CFD) simulation of respiratory particle delivery to the single conduit model to determine a mass of respiratory particles leaving an N conduit generation and a mass of respiratory particles deposited in an N+1 conduit generation (claims 1, 8, 13)
• determining a total mass of respiratory particles deposited in a generation of the lung corresponding to the N+1 conduit generation based on the mass of respiratory particles deposited in the N+1 conduit generation and a scaling factor for the N+1 conduit generation (claims 1, 8, 13)
• performing additional CFD simulations (claims 5, 12, 17)
• generating a reduced order model (ROM) to predict total masses of respiratory particles deposited (claims 5, 12, 17)
• perform a computational fluid dynamics (CFD) simulation of respiratory particle delivery to an N-1 conduit generation to determine an input parameter (claim 18)
• apply a reduced order model (ROM) using the input parameter to determine a total mass of respiratory particles deposited in a lung (claim 18)
Claims that further limit the JEs of base claims include:
• Claims 2, 9, and 14 respectively further limit the N conduit generation of claims 1, 8, and 13 to include an onward branch and a terminated branch
• Claims 2, 9, and 14 respectively further limit the mass of respiratory particles leaving the N conduit generation of claims 1, 8, and 13 to include a mass of respiratory particles leaving the onward branch and a mass of respiratory particles a terminated branch
• Claims 3, 10, and 15 respectively further limit the scaling factor of claims 1, 9, and 14 to a ratio
• Claims 4, 11, and 16 respectively further limit the scaling factor of claims 3, 10, and 15 to a sum of one plus the ratio
• Claim 19 further limits the ROM of claim 18 to the input parameter plotted against the total mass of respiratory particles deposited in the lung
• Claim 20 further limits the input parameter of claim 18 to total particle mass leaving the N-1 conduit generation and/or total air volume leaving the N-1 conduit generation
Step 2A Prong One Summary: The claims recite mental processes and mathematical concepts. When considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claims 1, 8, 13, and/or 18 (e.g., "generating a single conduit model," "perform a computational fluid dynamics (CFD) simulation," "determining a total mass of respiratory particles deposited in a generation of the lung," etc.) are directed to processes that may be performed mentally, as there are no particular limitations recited in claims 1, 8, 13, and/or 18 which would prevent the mental processes from being performed in the human mind or with pen and paper. Additionally, at least the listed example limitations inherently recite mathematical processes, as discussed in Specification paragraphs [0042-0044, 0048, 0051, 0053-0057], etc. Finally, such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea(s). (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see 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.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and/or outputting steps:
• receiving/receive a single conduit model (recited in claims 8 and 13)
Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology (see MPEP § 2106.04(d)(I)).
Additional elements of computer components:
• non-transitory computer-readable medium (recited in claims 1-7 and 18-20)
• a processor (recited in claims 1, 8, 12-13, and 17-18)
• a system (recited in claims 1, 8, and 13-18)
• a memory (recited in claims 8 and 13)
The claims require only generic computer components, which do not improve computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. In providing an explanation regarding improvement, it might be helpful to expound on the possible improvements mentioned in the Specification, e.g., at paragraphs [0005-0006] and [0024], and provide evidence of such an improvement, e.g., by comparison of increased accuracy of the claimed invention over conventional methods of CFD simulations of drug delivery in the lung. (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the judicial exceptions (abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of receiving/receive a single conduit model (recited in claims 8 and 13) do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network, and storing and retrieving information in memory, [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additional elements of computer components: The additional elements of a non-transitory computer-readable medium (recited in claims 1-7 and 18-20), a processor (recited in claims 1, 8, 12-13, and 17-18), a system (recited in claims 1, 8, and 13-18), and a memory (recited in claims 8 and 13) do not cause the claims to rise to the level of significantly more than the judicial exception, and as such do not provide an inventive concept; these are conventional computer components
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 1-8, 13, and 18-20, which are interpreted to recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited computer-readable medium, processor, and memory are used in generating models and performing simulations, etc.; as such, the computer-readable medium, processor, and memory act only as tools to perform the steps of data analysis and manipulation, and do not integrate the exception into a practical application or provide significantly more.
All limitations of claims 1-20 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.)
Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Claim Rejections - 35 USC § 103
Regarding claims 3, 4, 10, 11, 15, and 16, no prior art was found that teaches or suggests the following elements: "the scaling factor is based on a ratio of the mass of respiratory particles leaving the terminated branch and the mass of respiratory particles leaving the onward branch" (in claims 3, 10, and 15) and "the scaling factor is based on a sum of one and the ratio of the mass of respiratory particles leaving the terminated branch to the mass of respiratory particles leaving the onward branch." As such, claims 3, 4, 10, 11, 15, and 16 are not rejected under 35 U.S.C. 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.
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, 5-9, 12-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Koullapis (European Journal of Pharmaceutical Sciences, vol. 113, pages 132-144 (2018); cited on the attached form PTO-892) in view of Poorbahrami (Scientific reports, vol. 11(1):11180, pages 1-12 (2021); cited on the 04/01/2026 IDS and the 12/02/2024 Third Party Submission).
Regarding the claim 1 element (similarly recited in claims 8 and 13) for generating a single conduit model having conduit generations representing portions of corresponding generations of a lung, wherein the portions include at most two branches of the corresponding generations of the lung, Koullapis shows a one path (i.e., single conduit) model consisting of an idealized bronchial tree that spans generations 10–19 of generations of a lung (p.133, col.2, ¶ 4; and p.134, Fig.1).
Regarding the claim 1 element (similarly recited in claims 8 and 13) for performing a computational fluid dynamics (CFD) simulation of respiratory particle delivery to the single conduit model to determine a mass of respiratory particles leaving an N conduit generation and a mass of respiratory particles deposited in an N+ 1 conduit generation, and the claim 18 element to perform a CFD simulation of respiratory particle delivery to an N-1 conduit generation to determine an input parameter, Koullapis shows an objective of the current work is the prediction of deposition during a full breathing cycle in a simplified approximation of the deep lung, extending from generation 10 of the central conducting airways to the pulmonary acinar region (p.133, col.2, ¶ 2). Koullapis shows the open-source finite-volume CFD (computational fluid dynamics) code OpenFOAM is used to solve numerically the flow equations (p.137, col.1, ¶ 1). Koullapis shows inclusion of a physiologically realistic model of the acinar region, which enables the simulation of deposition over a complete breathing cycle (p.144, col.2, ¶ 2).
Regarding the claim 1 element (similarly recited in claims 8 and 13) for determining a total mass of respiratory particles deposited in a generation of the lung corresponding to the N+ 1 conduit generation based on the mass of respiratory particles deposited in the N+ 1 conduit generation for the N+ 1 conduit generation, wherein the scaling factor is based on the mass of respiratory particles leaving the N conduit generation, and the claim 2 element (similarly recited in claims 9 and 14) of the N conduit generation includes an onward branch and a terminated branch, and wherein the mass of respiratory particles leaving the N conduit generation includes a mass of respiratory particles leaving the onward branch and a mass of respiratory particles leaving the terminated branch, Koullapis shows relative deposition discriminated according to bronchial (B1–B9) and acinar generations (i.e., N, N+1, etc. generations); deposition fractions are normalized by the total deposition fraction for a
certain particle size (p.139, Fig.9 and col.1). Koullapis shows the deposition fraction, which is used to quantify deposition, is defined as the ratio of deposited particles in a segment to the total number of particles entering the model geometry for a particular size bin (p.137, col.2, ¶ 3). Koullapis shows the fate (% deposited, suspended, and exhaled) of particles in the overall deep lung model, shown as fraction of the total injected particles (p. 138, fig.7). Koullapis shows the average and standard deviation (error bars) of deposition efficiencies in B3–B9 generations and the acinus generation (p.140, fig.10).
Regarding the claim 5 element (similarly recited in claims 12 and 17) for performing additional CFD simulations of respiratory particle delivery to the single conduit model to determine total masses of respiratory particles deposited in the generation of the lung for a range of an input parameter, Koullapis shows simulating the airflow in only 9 bifurcations (B1–B9); then the same procedure is applied in the alveoli region (i.e., further simulations), resulting in the simulation of one sub-acinus unit instead of 512 (p.1356, col.1, ¶ 2).
Regarding the claim 5 element (similarly recited in claims 12 and 17) to predict the total masses of respiratory particles deposited in the generation of the lung, and the claim 18 element to apply a reduced order model (ROM) using the input parameter to determine a total mass of respiratory particles deposited in a lung, and the claim 19 element of the ROM is a scalar ROM having the input parameter plotted against the total mass of respiratory particles deposited in the lung, Koullapis shows the flow is anticipated to remain identical across the various bifurcations of a certain generation; and the reduction in flow complexity allows us hence to decompose the tree and simulate the airflow in one representative bifurcation at each generation level (i.e., a reduced order model) (p.135, col.1, ¶ 2).
Regarding the claim 6 element of a number of the additional CFD simulations is based on the range of the input parameter, and the claim 7 element (similarly recited in claim 20) of the input parameter is total particle mass entering the N conduit generation and/or total air volume entering the N conduit generation, Koullapis shows assessing the validity of our CFD-based deposition estimates, and shows the parameters of the models as the tidal volumes, volume at Functional Residual Capacity, volumetric flowrate profile, aerosol injection (p.137, col.2, ¶ 6).
Koullapis does not explicitly show a scaling factor of claims 1, 8, and 13 (taught by Poorbahrami).
While Koullapis shows a reduction in flow complexity, Koullapis does not explicitly state "reduced order models" of claims 5, 12, 17, and 18 (taught by Poorbahrami).
Regarding the scaling factor of claims 1, 8, and 13, Poorbahrami shows in Table 2, total deposition percentages are presented ( DepT ) as well as several scaling parameters to take into account differences in TV and body size; and calculating the deposition rate ( DepT × TV × RR , Table 2) which can be used to predict deposited dose of particulate matter in human lungs by multiplying this variable by the particulate matter concentration and exposure time (p.5, ¶ 4).
Regarding the claims 5, 12, 17, and 18 for generating a reduced order model (ROM), Poorbahrami shows the aerosol bolus is convected through the distal regions of the lung by solving reduced-order models (p.3, Fig.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the prediction of deposition in the lung using CFD of Koullapis with the reduced order model and scaling factors of Poorbahrami, as one of ordinary skill would have had a reasonable expectation of success, as Koullapis shows particle deposition in a simplified approximation of the deep lung, while Poorbahrami shows modeling realistic airway geometries to study the lung dosimetry; additionally, Koullapis and Poorbahrami are generally drawn to related teaching, and one of ordinary skill in the art would have understood how to and would have been motivated to combine the teaching of Koullapis and Poorbahrami, and as such, the combination would have been obvious.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
Prosecution Insights