DETAILED ACTION
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1- 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,996,279. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent is more limited than the claimed invention requiring each of the limitations required in claims 1-17 of the instant application. Note any differences not claimed by the patent would have been obvious in view of the references as discussed in the rejection herein below.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,996,280. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent is more limited than the claimed invention requiring each of the limitations required in claims 1-17 of the instant application. Note any differences not claimed by the patent would have been obvious in view of the references as discussed in the rejection herein below.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of co-pending Application No. 18/653,437 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires each of the limitations required in claims 1-29 of the instant application. Note all claims are additionally provisionally rejected because any differences not claimed by the reference application would have been obvious as discussed in the rejection herein below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
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 1-29 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 lacks written description for requiring “wherein the data analysis system is further configured to: compile the optical data with unique mass spectral data associated with particle using data fusion; and compare the compiled optical data with a training data set comprising of a knowledge base of known aerosol particles to predict composition.”
Specifically, MPEP 2161.01 recites: “the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. ”
Here, the instant specification only defines 1) using data fusion (see for instance [0068]) 2) analyzing spectra with data fusion and machine learning algorithms (0082) 3) a review of data fusion techniques provided by Castanedo incorporated by reference ([0069]).
However, there is insufficient disclosure as to how data fusion is conducted to compile the specifically claimed data.
Initially, Castanedo was improperly incorporated by reference. Specifically 37 CRF 1.57 (d)-(e) recites:
“(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.”
Here, the inventive concept is disclosed to be the last two clauses of the claim. Specifically, paragraph [0069] teaches “The large amount of data related to each particle in the aerosol beam may then be filtered and analyzed using data fusion protocols in data analysis system 110 to identify the composition and type of particles in real-time and with a high accuracy, sensitivity, and specificity.”
Data fusion is considered to be essential matter and thus incorporation by reference of a non-patent literature is not sufficient to demonstrate possession the claimed subject matter. Therefore, the incorporation by reference is insufficient to demonstrate possession of the claimed “compile the optical data with unique mass spectral data associated with each selected indexed particle using data fusion”
However, even if it was, the cited Castanedo is merely a discussion of data fusion in general. The claim requires the data fusion to specifically “compile the optical data with unique mass spectral data associated with each particle”. Castanedo fails to describe particles, optical data or mass spectral data. Therefore, Catanedo is insufficient to provide written description as to how data fusion is used to “compile the optical data with unique mass spectral data associated with each selected indexed particle”.
MPEP 2161.01 further recites:
“ original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. ”
Here, the instant specification merely suggests that data fusion is used, however fails to teach any specific data fusion technique to achieve the claimed result of compiling the optical data with unique mass spectral data associated with each particle.
As evidenced by Castanedo data fusion techniques can be classified into three nonexclusive categories including “data association” (see page 1, right column, second to last paragraph). Castanedo continues in the following paragraph by reciting “Section 3 describes the most common methods for data association”. In other words, Castanedo is a broad overview of different non-exhaustive methods of data fusion, however does not resolve the problem of the specific data fusion technique to achieve the claimed result of compiling “the optical data with unique mass spectral data associated with each particle”.
In other words, it was recognized by Castanedo that there are any number of data fusion techniques. However, there is no discussion as to which data fusion technique is used and how it is specifically conducted so as to achieve the claimed result of compiling the optical data with unique mass spectral data associated with each selected indexed particle.
Consider Niu et al. (Niu et al., “Individual Micron-Sized Aerosol Qualitative analysis-combined Raman Spectroscopy and Laser-Induced breakdown Spectroscopy by optical trapping in Air”, analytical chemistry, 2023) which teaches single particle mass spectrometry and three data fusion mythologies (early fusion, intermediate fusion and late fusion). Niu et al. notes varying accuracies (see abstract). Figure 12 in Nui shows the data fusion strategies in detail. That is, one of ordinary skill in the art would expect a similar level of detail to demonstrate possession. In contrast, the instant specification provides no details with respect to the data fusion mythology to compile the claimed data.
A different way to reach the same conclusion is to consider all the various ways to perform data fusion implemented as a genus, and then ask if a representative number of species have been disclosed. While as evidenced by Castanedo, there is a non-exhaustive list a of data fusion models, there is no disclose actual data fusion model to achieve the claimed result. The issue is that significant effort is required to determine for a given data fusion technique with the set of data to perform to an acceptable accuracy (see Niu, abstract). Therefore, given that the accuracy varies depending on the type of data fusion model, and there is no disclosure of the specific model used. The issue is raised as to whether there is sufficient disclosure of the data fusion to compile the claimed data to an acceptable accuracy to achieve the claimed result of comparing the compiled data with training data set to predict a composition.
Lastly, it is noted that MPEP 2161.01 (I) recites:
“ It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. ”
Here, there is no disclosure with respect to how the result is achieved of compiling the specifically claimed data using data fusion.
Similarly, with respect to compare the compiled optical data with a training data set comprising of a knowledge base of known aerosol particles to predict composition.”
The instant specification teaches in paragraph [0082] that a supervised learning machine, unsupervised machine learning methods and semi-supervised may be used is used for this step. Additionally, paragraph [0086] teaches support vector machines may also use classification to achieve this step. However, there is no practical disclosure as to how these machine learning algorithms are used to compare optical data with training data set or the accuracy of the prediction of the composition and the details on the effectiveness of the machine learning model is expected from a reduction to practice. Niu et al. is evidence of one machine learning method for prediction (see page 2880, last paragraph in right column teaching stacking model with SVM classifier and supporting information, page s11 teaching the specifics of the stacking classifier). However, as disclosed the instant specification teaches any number of machine learning algorithms with no disclosure of any specific architecture to achieve the claimed results when the accuracy is known to vary dependent on the model (See page 2880, right column, last paragraph and supporting information tables S8 and s9 on page S15). That is, except for the general disclosure of use of a machine learning algorithm to predict a composition via comparison of compiled optical data with a training data and a list of highly general machine learning algorithms, the specification is silent with respect to the specific parameters to achieve the claimed result of comparison of claimed data to predict a composition.
Moreover, as evidenced by Christopoulos et al. (“a machine learning approach to aerosol classification for single particle mass spectrometer” (Submitted with IDS of 22 April 2024 of co-pending application 18/642553))) teaches “the choice of supervised or unsupervised machine learning will depend on the researcher’s use case, and each method has unique advantages and disadvantages…it is noted that comparisons between all machine learning models are sensitive to user defined parameters and algorithm implementation”. This suggests the machine learning algorithm to perform the claimed comparison step is not predictable, as it depends specifically on the user defined parameters, algorithm implementation and researcher’s use case. As the specification is devoid of any of these parameters, specific use case or algorithmic implementation, one of ordinary skill in the art, as evidenced by Christopoulos would not understand the result to be supported by high level discussion of ML algorithms. Moreover, as distinct from Chistopoulos, the instant specification is devoid of any specific steps to perform the claimed result. That is, Chistopoulos teaches a specific method of implementing ML into single particle mass spectrometry, however there is no specific disclosure of the architecture used or how it is implemented to achieve the claimed result.
Therefore, claim 1 fails to meet the written description requirement under 35 USC § 112(a).
Claims 2-21 fail to meet the written description requirement by virtue of their dependencies on rejected claim 1.
Claim 22 recites commensurate limitations and is rejected for the same reasons above.
Claims 23-29 fail to meet the written description requirement by virtue of their dependencies on rejected claim 22.
Claims 5 and 25 lacks written description for requiring “at least about 100 microseconds”, specifically, the instant specification teaches a range of 100 to 200 microseconds ([0015]). MPEP 2163.05 (III) recites “A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement.” Here there is no support for outside the 100 to 200 microsecond range.
Claims 14, 17 and 29 also have unbounded ranges that allow the claims to read outside of disclosed embodiments.
Moreover, claim 20 fails to meet the written description requirement for further limiting the device to include a machine learning engine. As discussed above, there is insufficient disclosure to support possession of a machine learning engine to achieve the claimed prediction.
Claim Rejections - 35 USC § 112
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 1-29 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 lacks enabling disclosure for reciting “compile the optical data with unique mass spectral data associated with each selected indexed particle using data fusion; and compare the compiled optical data with a training data set comprising of a knowledge base of known aerosol particles to predict composition”.
MPEP 2161.01 (III) provides examples of enablement issues due to missing information for computer implemented functional limitations. MPEP 2161.01(III) recites:
1) When a claim is not limited to any particular structure for performing a recited function and does not invoke 35 U.S.C. 112(f), any claim language reciting the ability to perform a function per se would typically be construed broadly to cover any and all embodiments that perform the recited function. Because such a claim encompasses all devices or structures that perform the recited function, there is a concern regarding whether the applicant's disclosure sufficiently enables the full scope of protection sought by the claim. In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 229 (CCPA 1971);
2) The specification need not teach what is well known in the art. However, applicant cannot rely on the knowledge of one skilled in the art to supply information that is required to enable the novel aspect of the claimed invention when the enabling knowledge is in fact not known in the art. ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941, 94 USPQ2d 1823, 1827 (Fed. Cir. 2010) ("ALZA was required to provide an adequate enabling disclosure in the specification; it cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification."); Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d 1108, 1114-15 (Fed. Cir. 2007) ("Although the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be enabled in the patent."). The Federal Circuit has stated that "‘[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.’" Auto. Technologies, 501 F.3d at 1283, 84 USPQ2d at 1115 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)). See also Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1159-61, 2019 USPQ 2d 415844 (Fed. Cir. 2019). The rule that a specification need not disclose what is well known in the art is "merely a rule of supplementation, not a substitute for a basic enabling disclosure." Genentech, 108 F.3d at 1366, 42 USPQ2d 1005; see also ALZA Corp., 603 F.3d at 940-41, 94 USPQ2d at 1827. Therefore, the specification must contain the information necessary to enable the novel aspects of the claimed invention. Id. at 941, 94 USPQ2d at 1827; Auto. Technologies, 501 F.3d at 1283-84, 84 USPQ2d at 1115 ("[T]he ‘omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required.’") (quoting Genentech, 108 F.3d at 1366, 42 USPQ2d at 1005).
Under 1) above, the above cited features of claim 1 is not limited by structure and encompasses all devices or structures that perform the recited function raising the question as to whether the claim is enabled for the full scope of the claimed language. As discussed above, the specification only discusses the use of machine learning algorithms to perform the claimed function, however the claim has no requirement for machine learning algorithms. Even if the claim were amended to include a machine learning algorithm, there is no representative number of examples in order to make and use the claimed device. That is, the breath of the claims covers any means of comparing compiled data and training set to predict a composition, wherein the only disclosed suggestion is via machine learning algorithms (which are only disclosed with a high degree of generality). 2) the nature of the invention is to achieve real time identification using data fusion and comparative techniques, however again there is no disclosure of the specific data fusion technique, or comparison methodology or how those techniques are specifically operated 3) the state of the prior art is discussed in paragraph [0006]-[0007] of the instant specification which requires purification resulting in a long delay in identification. The instant specification teaches the solution to this problem is via data fusion protocols ([0069]) that are used with Machine learning techniques ([0082]) to provide real-time identification. However, given that one of ordinary skill in the art as evidenced by paragraph [0006] would not use such techniques and the data fusion techniques are disclosed with a high degree of generality, there is not enough information disclosed to allow one of ordinary skill in the art to make and use the claimed invention. Moreover, as evidenced by Nui discussed above, data fusion and machine learning techniques result in a variety of accuracies and as evidenced by Castanedo there is any number of data fusion techniques. Therefore, without further disclosure as to the particular methods of data fusion and comparison, one of ordinary skill in the art would understand the actual accuracy to be unpredictable. Moreover, the specification is silent of any direction or working examples that would enable one of ordinary skill in the art to achieve the claimed results of compiling optical data with unique mass spectral data associated with each particle using data fusion and compare the compiled optical data with a training data set to predict composition. Therefore, taken together, there is not enough information disclosed to make and use the device.
Lastly, it is noted that support for data fusion, the specification relies on Castanedo. However, as discussed above the nature of the invention is to perform real-time identification via data fusion. As discussed in MPEP 2161.01 (III) above “applicant cannot rely on the knowledge of one skilled in the art to supply information that is required to enable the novel aspect of the claimed invention when the enabling knowledge is in fact not known in the art. ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941, 94 USPQ2d 1823, 1827 (Fed. Cir. 2010)”.
Here, the inventive concept is using data fusion to compile data so as to enable real-time identification, however the specification relies on Castanedo which provide no actual method to compile optical data with unique mass spectral data associated with each particle using data fusion. Instead, Castanedo is evidence of the wide variety of data fusion techniques without resolving the issue of how the claimed results are achieved.
Therefore claim 1 fails to meet the enablement requirement under 35 USC § 112(a).
Claims 2-21 fail to meet the enablement requirement by virtue of their dependencies on rejected claim 1.
Claim 22 recites commensurate limitations and is rejected for the same reasons above.
Claims 23-29 fail to meet the enablement requirement by virtue of their dependencies on rejected claim 21.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1/5, 6, 22/25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLaughin (US pgPub 2022/0044921)(note claim 5 does not have disclosure of the claimed delay time in any of the parent applications, therefore the earliest effective filing date is the filing date of the instant application (05/24/2024). Therefore, McLaughlin is available as prior art for the dependent claims. MPEP 211.05 (I)B1. Moreover, MPEP 2112(II) recites: “"[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999)”. Here, the instant application teaches at paragraph [00118] “delay time may be defined as the time period that extends between the detection of a particle using the continuous laser beam and the ionization of the particle using the IR pulse ionization laser beam. As such, the distance “d” between the center line 1313 of the continuous trigger laser beam and center line 1314 of the IR pulse ionization laser beam may be configured to provide a delay time (or dead time) of at least about 100 microsecond”. Wherein the distance is disclosed in paragraph [00134] as 50 microns. That is, the instant specification recognized a previously unknown feature that a separation distance of 50 micron would result in a delay time of 100 microseconds2.
It is noted, that while McLaughlin ‘921 teaches a 50 micron separation between centerlines of the timing laser and the pulse ionization laser ([0012]), McLaughlin did not recognize that such a distance would result in a delay time of 100 microseconds. Therefore, the filing date is given the later date and the McLaughlin is interpreted to inherently teach the claimed delay because the same distance as required by the instant specification is what allows for the claimed delay time. Since McLaughlin teaches the disclosed distance the delay time is understood to be an inherent result).
Regarding claim 1/5, McLaughlin teaches a mass spectrometer system (fig. 1) for detecting the composition of biological aerosol particles (intended use), the system comprising:
an aerosol beam generator (102, figure 9c, 902) to generate an aerosol beam of single particles (as seen in figure 1);
a single guide tube (modified example in figure 9c showing particle guide 910) disposed downstream of the aerosol beam generator (downstream 902) and configured to urge particles to flow nearabout the longitudinal axis of the guide tube (as seen in figure 9c);
a continuous laser generator (903) to generate a single continuous laser beam ([0045]), and in association with a control system (fig. 1, 110/111), configured to:
hit each particle with the single continuous laser beam as each particle exits the guide tube ({0046], last sentence) and enters the continuous laser beam to generate scattered light characteristic of each particle (scatter suggested by continuous laser in paragraph [0031], thus the same applies to 903. See also scatter in figure 9D); and
determine optical properties of each particle in association with one or more light scattering detectors and generate optical data in association with a data analysis system (scattering devices taught in paragraph [0031] to measure shape or size [0035]. Fig. 9D shows a scatter graph, thus inherently requiring detection of scatter);
an IR pulse ionization laser generator (ionization laser 908, [0032] teaches IR pulse ionizes biomolecules) triggered by the continuous laser (inherent to a trigger laser) when each particle enters the continuous laser beam (as seen in figure 9c), and configured to fire an IR laser pulse ionization beam to hit each particle ([0046], last sentence) and generate ionized fragments associated with each particle ([0032] teaches IR pulse may op open or burst each particle and generate ionized small and large fragments); and
a TOFMS detector (fig. 1, 106) to analyze the ionized fragments (inherent to TOFMS detector), and generate unique mass spectral data associated with each particle ([0031]), wherein the data analysis system is further configured to: compile the optical data with unique mass spectral data associated with each particle using data fusion ([0031]); and compare the compiled data with a training data set comprising of a knowledge base of known aerosol particles to predict composition ([0031])
McLaughlin further teaches wherein each of the continuous timing laser and the pulse ionization laser is characterized by a respective center line ([0012] teaches “The distance between the center lines of the timing laser beam and the pulse laser beam may be about 50 μm. The exemplary method may further comprise the step of indexing each particle in the aerosol particle beam using the timing laser beam”), and wherein the distance between the center line of the continuous timing laser and the center line of the pulse ionization laser is configured to provide a delay time of at least about 100 microsecond, wherein the delay time is defined as a time period between the triggering of the IR pulse ionization laser generator and the firing of the IR pulse ionization laser beam (while this result is not recognized by the McLaughlin, the instant specification teaches this is necessarily the case see paragraph [00118] and [0134] of the originally filed specification which suggests a 50 micron centerline separation ([0134]) will result in a 100 microsecond delay time ([00118]). MPEP 2112(II) recites ““"[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”. Here because the separation distance is the same the delay time must necessarily result as evident by the instant disclosure).
Regarding claim 6, McLaughlin teaches wherein the delay time is between about 100 µs and about 200 µs (same rational as above in claim 5 by virtue of McLaughlin’s disclosure of a 50 micron centerline separation).
Claim 22/25 is rejected under the same rational as above. McLaughlin additionally teaches the required indexing in paragraph [0011].
Regarding claim 26, McLaughlin teaches wherein the delay time is between about 100 µs and about 200 µs (same rational as above in claim 5 by virtue of McLaughlin’s disclosure of a 50 micron centerline separation).
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.
Claims 1-4, 10-13, 16-20, 22-24 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over McLaughlin et al. (WO2021061247) (the national stage application filed under 371 (17/6923,598) published as US 2022/0252545 is used for the purposes of citing paragraphs) (note the inventors are different from the instant application, therefore, WO2021061247 reference is available as prior art under 102(a)(1) and 102(a)(2). The instant application is a CIP to PCT/US2020/040023 which does not disclose the claimed single guide tube, therefore the effective filing date of the instant claims is 21 October 2021 (i.e. the filing date of parent application 17/507,755)) in view of Prather (USPN 5,681,752) or Ehara (USPN 5,428,220) or Prather (US pgPub 2011/0071764).
Regarding claim 1, McLaughlin a mass spectrometer system (fig. 1) for detecting the composition of biological aerosol particles including water bound to the surface of the particles (inherent to the apparatus of figure 1, note this is intended use), the system comprising:
an aerosol beam generator (102) to generate an aerosol beam of single particles ([0026]);
a series of lenses ([0026])
a continuous laser generator (112) to generate a single continuous laser beam, in association with a data analysis system (as seen in figure 1, data analysis system 110 and paragraph [0026] and [0030]), configured to:
hit each particle with the single continuous laser beam as each particle exits the series of lenses and enters the continuous laser beam to generate scatter light characteristic of each particle (112 is shown to hit particles exiting 102, wherein particles travel into chamber 104 via a series of lenses ([0026]) thus after exiting the series of lenses, wherein paragraph [0026] teaches 112 may measure optical properties and paragraph [0030] teaches such a laser may be a continuous laser); and
determine optical properties of each particle in association with one or more laser scattering detectors and generate optical data in association with a data analysis system ([0026]);
an IR pulse ionization laser generator (108) triggered by the continuous laser when each particle enters the continuous laser beam ([0026]), and configured to produce an IR laser pulse ionization beam to hit each particle and generate ionized fragments associated with each particle ([0027]),
a TOFMS detector (106) to analyze the ionized fragments ([0026]), and generate unique mass spectral data associated with each particle ([0026]), wherein the data analysis system is further configured to: compile the optical data with unique mass spectral data associated with each particle using data fusion; and compare the compiled optical data with a training data set comprising of a knowledge base of known aerosol particles to predict composition ([0026]).
While, McLaughlin teaches a series of lenses to collimate the beam from the generator to the chamber 104 ([0026]), McLaughlin fails to disclose a single guide tube disposed downstream of the aerosol beam generator and configured to urge particles to flow nearabout the longitudinal axis of the guide tube.
However, aerodynamic lenses are well known to the art. Specifically, Prather (USPN 5,681,752) teaches a single guide tube disposed downstream of the aerosol beam generator and configured to urge particles to flow nearabout the longitudinal axis of the guide tube (interface 11, figure 2 shows a single tube formed of successive vacuum stages to urge particles to flow nearabout the longitudinal axis of the interface col. 4, lines 57-67 through col. 5, lines 1-25 detailing the interface 11 to improve collection and linearization of particles along the particle path 13). Alternatively, Ehara (USPN 5,428,220) teaches an outlet tube 10 which would inherent urge particles to flow nearabout the longitudinal axis 38. Alternatively, Prather (US pgPub 2011/0071764) teaches an aerodynamic lens 210 seen in figure 2a which also urges particles into the aerosol mass spectrometer.
Any of the references modifies McLaughlin by suggesting the structure of the focusing lenses or outlet into the ionization region.
Since both inventions are directed towards aerosol mass spectrometers, it would have been obvious to one of ordinary skill in the art to incorporate the aerodynamic lenses of either Prather reference or the outlet of Ehara in the device of McLaughlin because it would resolve the method of interfacing the aerosol generator of Mclaughlin to the chamber. Moreover, as in Ehara the outlet to establish a linear or laminar aerosol flow so as to be better aligned for irradiation in McLaughlin.
Regarding claim 2, McLaughlin in view of Prather teaches wherein the aerosol beam generator is configured to output the aerosol beam of single particles at a particle velocity of less than about 20 m/s (Prather (US5681752) figure 4 shows a graph indicating less than 20 m/s via interface).
Regarding claim 3, McLaughlin teaches wherein the optical properties include one or more of particle size, particle shape, and fluorescence of each particle ([0030]).
Regarding claim 4, McLaughlin teaches wherein the continuous laser generator in association with a data analysis system is further configured to: index each particle in the aerosol beam of single particles; and select which indexed particle is to be ionized based on analysis of the optical data ([0026]).
Regarding claim 10, McLaughlin teaches wherein the size of the ionization region of the IR pulse ionization laser beam is between about 100 µm and 150 µm (see claim 38 of McLaughlin).
Regarding claim 11, McLaughlin teaches wherein the travel time of each particle from the aerosol beam generator to the ionization region of the ionization pulse laser beam is less than about 1 s ([0028]).
Regarding claim 12, McLaughlin teaches wherein the IR laser pulse is characterized by a wavelength of between about 2.7 µm and about 3.3 µm ([0028]).
Regarding claim 13, McLaughlin teaches wherein the IR laser pulse wavelength is about 3 µm ([0028]).
Regarding claim 16, McLaughlin teaches wherein a pulse width of the IR pulse ionization laser beam is between about 5 nanosecond (ns) and about 10 ns ([0010]).
Regarding claim 17, McLaughlin teaches wherein a pulse repetition rate of the IR pulse ionization laser beam is at least about 40 Hz ([0040] 1 Khz is greater than 40 Hz).
Regarding claim 18, McLaughlin teaches wherein the IR laser pulse is generated using at least one of a Er:YAG laser and a OPO laser ([0011]).
Regarding claim 19, McLaughlin teaches at least one of a fluorescence detector, a LIBS detector, and a Raman spectrometer to analyze photons associated with each particle generated when each particle reaches the ionization region ([0012]).
Regarding claim 20, McLaughlin teaches a machine learning engine disposed in data communication with the data analysis system, wherein the machine learning engine is configured to improve the prediction of composition over time using machine learning methods ([0033]).
Claim 22 is commensurate with claim 1 and is taught as in the citations herein above, indexing is taught in the same citations discussed above.
Regarding claim 23, McLaughlin teaches wherein the optical properties include one or more of particle size, particle shape, and fluorescence of each particle ([0030]).
Regarding claim 24, McLaughlin in view of Prather teaches wherein the aerosol beam generator is configured to output the aerosol beam of single particles at a particle velocity of less than about 20 m/s (Prather (5681752) figure 4 shows a graph indicating less than 20 m/s via interface).
Regarding claim 28, McLaughlin teaches wherein the IR laser pulse wavelength is about 3 µm ([0028]).
Regarding claim 29, McLaughlin teaches wherein a pulse repetition rate of the IR pulse ionization laser beam is at least about 40 Hz ([0040] 1 Khz is greater than 40 Hz).
Claims 7-8, 14-15 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McLaughin in view of either Prather reference or Ehara and further in view of Reents (US pgPub 2004/0056188).
Regarding claims 7-8, 14-15 and 27, McLaughlin in view of Prather references or Ehara fails to disclose the dimensions of the tube and ionization region and peak power.
However, Reents teaches wherein the size of the ionization region is between about 100-150 microns (0022 teaches laser spot sizes of .1 mm2, thus having a length of 100 microns), wherein the nominal inside diameter of the guide tube is about twice the size of the ionization region ([0021] diameter of .05 mm vs ionization region of .1 mm), wherein the nominal length of the guide tube is between about 1 in. and about 5 in. ([0021] .1 m is about 3 inches) and peak energy per pulse of IR pulse ionization laser beam to be between 5 millijoules and 10mJ per pulse([0022] 10 mJ power and pulsed beam).
Reents modifies the combined device by suggesting dimensions for the transport tube.
Since both inventions are directed towards aerosol mass spectrometry, it would have been obvious to one of ordinary skill in the art to adopt the dimensions of Reents in the combined device because these dimensions assist in collimating the particle laden gas stream and advantageously eliminate the need for mechanical pumping along the path of the capillary. Moreover, the dimensions resolve the issue as to what dimensions to set the aerodynamic lens tube of Prather and the beam spot size (i.e. ionization region) to facilitate ionization. Moreover the peak power would have been obvious because it enables the full characterization of the particle laden gas stream because such high powers ensure mass independent ablation of elemental constituents of the particle ([0023])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combined device in view of Ishii (US pgPub 2014/0341780).
Regarding claim 9, the combined device fails to disclose the material of the tube. However Ishii teaches a tube made of stainless steel ([0020]).
Since both inventions are directed towards the transport of a sample, it would have been obvious to one of ordinary skill in the art to use a stainless steel material as suggested by Ishii because stainless steel has a high corrosion resistance.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over McLaughin in view of either Prather reference or Ehara (interpreting McLaughlin not to teach overlapping) and further in view of in view of Fergenson (US pgPub 2009/0250606).
Regarding claim 21, McLaughlin wherein the continuous timing laser generator and the IR pulse ionization laser generator are configured to produce the continuous laser beam and the IR pulse ionization laser beam ([0012])
However, Fergenson teaches overlapping timing and firing laser ([0029]).
Fergenson modifies McLaughlin by suggesting placing the desorption ionization about coaxial with a tracking laser.
Since both inventions are directed towards aerosol mass spectrometers, it would have been obvious to one of ordinary skill in the art to place a tracking laser about coaxial and thus overlapping with the desorption laser as taught by Fergenson in the combined device because every particle that is detected will be hit by the desorption ionization laser and no particles will be missed ([0029]), therefore ensuring ever particle is tracked.
Relevant art of interest to the applicant:
The applications associated with USPN 11,996,279 and USPN 11,996,280 suggest many of the limitations of the independent claims however fail to suggest the data fusion and comparison steps of each claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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/MICHAEL J LOGIE/ Primary Examiner, Art Unit 2881
1 a claim in a continuation-in-part application recites a feature which was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application, but which was first introduced or adequately supported in the continuation-in-part application, such a claim is entitled only to the filing date of the continuation-in-part application.
2 It is noted that paragraph 0118 refers to figure 13, whereas paragraph [00134] refers to figure 9. It is interpreted that the distance in paragraph [0118] is referring to the distance provided in paragraph [00134]. If it is not, than there is no disclosure of the distance between centerlines necessary to create the delay of 100 microseconds. If it is not the distance of paragraph [00134], the dependent claims would be additionally rejected under 35 USC 112(a) for failing to disclose the distance to achieve the claimed result of the delay time.
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