Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 28 Apr 2026 has been entered.
Claims 11-33 remain pending in the application.
Claims 11-19, 21, 23, 25, and 27-33 are amended.
Claims 13-20 and 24-31 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. The examiner notes that claims 13-18 and 24-31 require species alternative to those elected by the applicant. For example, claim 24 requires a mixture of neutral lipids instead of the elected DMPC. Additionally, the examiner notes that catalase was the elected protein drug and that catalase has a molecular weight of 250 kDa and an isoelectric point of 5.4 (see [0018] of the instant specification). Claims 13-18 and 25-31 require a protein drug with either a different molecular weight or isoelectric point and thus require a different protein drug from the elected catalase.
Claims 11, 12, 21-23, 32 and 33 are under consideration to the extent of the elected species, i.e., that the protein drug is catalase, the apolipoprotein is ApoE, the neutral lipid is DMPC and the anionic lipid is DOPA.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 28 Jan 2026 are hereby withdrawn in light of applicant’s amendments of the specification.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 28 Jan 2026 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejection of claims 11, 12, and 21-23 under 35 U.S.C. 103 as being unpatentable over Huang et al. (Nature Communications, 8:15144, published 10 May 2017, listed in IDS filed 23 Oct 2023) in view of Liu et al. (Biomaterials 35 (2014) 8002-8014), and Kratzer et al. (Journal of Controlled Release 117 (2007) 301–311) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the rejection set forth below.
The rejection of claims 32 and 33 under 35 U.S.C. 103 as being unpatentable over Huang et al. (Nature Communications, 8:15144, published 10 May 2017, listed in IDS filed 23 Oct 2023) in view of Liu et al. (Biomaterials 35 (2014) 8002-8014), and Kratzer et al. (Journal of Controlled Release 117 (2007) 301–311) as applied to claims 11, 12 and 21-23 and further in view of and Phua et al. (ACS Nano 2019, 13, 4742−4751) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the rejection set forth below.
Rejections Maintained
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 11, 12, 21-23, 32 and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
Claim 11, 12, 21-23, 32 and 33 are directed to a nanocomplex comprising protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein.
The claims further require certain percentages of each of the components and claims 12, 21-23 and 33 recite further alternative limitations on the components for the nanocomplex that further define each of the components.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following analysis is based on the flowchart found in MPEP §2106(III) and is used when considering whether or not a claimed invention recites eligible subject matter.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, claims 11, 12, 21-23, 32 and 33 are directed to a composition of matter.
Step 2A: Is the claim directed to a judicial exception (i.e. a law of nature, a natural phenomenon (product of nature) or an abstract idea)?
Analysis of Step 2A is divided into two prongs.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
The claims are directed to a nanocomplex comprising protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein in specific amounts. Each of the components of the nanocomplex as recited are natural in origin. As noted, there are optional limitations listed in the dependent claims that further define the components but they do not require elements that include non-natural components.
Since the composition contains products which are naturally-occurring, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein as they occur separately in nature. There is no indication that mixing the protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein would change the structure, function or other characteristics of the individual components in any way. Rather, when mixed, each of the individual components would retain its naturally-occurring structure and function.
Even when considering the distinct percentages of each component as recited, the percentages do not impart any markedly different qualities or characteristics to the components. Thus, by combining the claimed protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein the applicants have not altered the components in any significant way.
Therefore, claims 11, 12, 21-23, 32 and 33 recite a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Claims 11, 12, 21-23, 32 and 33 do not recite an additional element beyond the natural components of protein drug, hyaluronic acid, protamine, a neutral lipid, an anionic lipid and apolipoprotein, in specific ranges of the components and that they are a nanocomplex. As discussed above, there is no indication that the percentage of each component in the composition imparts any markedly different qualities or characteristics to the components. Further, the requirement of a “nanocomplex” does not add a meaningful distinction of the components beyond noting that they are complexed together, which may happen naturally. Thus, claims 11, 12, 21-23, 32, and 33 do not present elements or components in addition to the judicial exception that could be interpreted as imposing a meaningful limitation over the claim scope. Accordingly, claims 11, 12, 21-23, 32 and 33 do not integrate the recited judicial exception into a practical application and the claims are therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, claims 11, 12, 21-23, 32, and 33 do not recite an additional element beyond the natural components of the composition and specific amounts of the components and the form of a nanocomplex. The presence of each of the components in a single composition would necessarily require distinct percentages of each component in the composition and there is nothing to indicate that the percentage of each component as recited offers a distinct or inventive concept to the claim. Therefore, claims 11, 12, 21-23, 32 and 33 do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claims as a whole do not amount to significantly more than the judicial exception.
Conclusion: Claims 11, 12, 21-23, 32 and 33, which are directed toward a composition comprising the natural components of protein drug, hyaluronic acid, protamine, a neutral lipid an anionic lipid and apolipoprotein, are not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claims 11, 12, 21-23, 32 and 33 are directed toward a judicial exception under 35 USC 101. Claims 11, 12, 21-23, 32 and 33 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.
Response to Arguments
Applicant's arguments filed 28 Apr 2026 have been fully considered but they are not persuasive. Applicant states in the remarks (pages 20-22) and in a declaration filed 28 Apr 2026 that the nanocomplex is not a natural product as it is an artificially self-assembled nanocomplex with a core-shell structure, which can achieve more efficient intracellular delivery of the protein drug and has different characteristics from complexes that are simply mixed. The applicant looks to a flowchart in Fig A which corresponds to methods I or II in the specification [0154-0163]. The examiner does not find this persuasive. The examiner notes that the claims merely require a “nanocomplex” and do not require any kind of core-shell structure or any specific method steps that would result in such a structure. The complex invented by the applicant may provide different characteristics from complexes that are simply mixed but the claims do not require the specific nanocomplex that seems to be the invention described in the remarks. Even if it is not the complex invented by the applicant, the applicant acknowledges in the remarks (page 21) that simple mixing will result in a certain type of aggregation between the components.
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Giving the claims their broadest reasonable interpretation, an electrostatic aggregation between the components may be understood as a nanocomplex. In addition, the steps shown in Fig A and described in the specification for method I or II appear to only mention combining the components and then mixing. The applicant states that their complex has different results from a complex of the components that were simply mixed, but the applicant has not made this distinction clear and based on the evidence presented the nanocomplex appears to be prepared from simple mixing steps.
New Grounds of Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 11, 12, 21-23, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (Nature Communications, 8:15144, published 10 May 2017, listed in IDS filed 23 Oct 2023) in view of Liu et al. (Biomaterials 35 (2014) 8002-8014), Kratzer et al. (Journal of Controlled Release 117 (2007) 301–311) and Phua et al. (ACS Nano 2019, 13, 4742−4751) as evidenced by the instant specifcation.
Huang teaches apolipoprotein E3 reconstituted high-density lipoprotein nanostructures that encapsulate siRNA-loaded calcium phosphate core and facilitates it penetrating the blood-brain barrier and targeting glioblastoma cells in a micropinocytosis-dependent manner (abstract). Huang teaches that lipoproteins are natural nanoparticles that are suitable platforms for delivering imaging and therapeutic agents (page 2 bottom left column) and that apolipoprotein E3-reconstituted high-density lipoprotein (ApoE-rHDL) is an efficient nanoplatform with blood brain barrier permeability (page 2 top right). Huang teaches the siRNA was entrapped by calcium phosphate nanoparticles which were introduced as a solid core of the lipoprotein (page 2 right column middle). Huang teaches that the lipoprotein was formed using phospholipids DOPA and DMPC and apolipoprotein E3 (page 2 bottom right), rendering obvious the elected species of anionic and neutral lipids and the apolipoprotein of the instant claims. Huang teaches that cellular uptake into glioblastoma cells was stimulated by excessive but relatively low concentrations of ApoE and remarkably inhibited at extremely high concentrations of ApoE3 (page 4 left column). Huang teaches the cellular uptake of the lipoprotein was dependent on the concentration of DMPC (Figure 2). Huang teaches the preparation of particles with sizes ranging from approximately 15-70 nm (Fig 1c), rendering obvious the particle size of claim 33.
Huang does not teach the inclusion of hyaluronic acid or protamine or the protein drug catalase (i.e. the elected species of protein drug). These deficiencies are made up for in the teachings of Liu, Kratzer and Phua. It is noted that the inclusion of a protein drug is not required as the limitation of the claims includes 0% protein drug.
Liu teaches high density lipoproteins, which are nanoparticles composed of biological lipids and apolipoproteins (page 8002 bottom right) that are decorated with hyaluronic acid (title). Liu teaches that reconstituted HDL (rHDL) is extensively applied in pharmaceutical development as an effective drug delivery system (page 8003 top left). Liu teaches that rHDL has a high affinity to cells expressing SR-BI and that hepatic cells over express SR-BI which results in the uptake of rHDL by the liver and that it is desirable to decrease unintended drug accumulation in the liver (page 8003 top left). Liu teaches that the cell adhesion molecule CD44 is mainly up-regulated on the surface on injured endothelial cells at inflammatory sites such as tumors and atherosclerotic lesions and that hyaluronic acid has been employed to improve the targeting efficiency to solid tumors via CD44-mediated uptake (page 8003 left column). Liu teaches that hyaluronic acid rHDL demonstrated reduced uptake by the liver via SR-BI and improved distribution to atherosclerotic lesions by adhering to CD44 (Figure 1, page 8013 Conclusion). Liu teaches hyaluronic acid particles with a zeta potential of -25.66 ± 0.65 which is close to -25 and renders obvious the zeta potential of claim 33.
Kratzer teaches that the blood brain barrier is an obstacle for efficient delivery of neuropharmaceuticals to the brain (page 301 introduction). Kratzer teaches that protamine-oligonucleotide nanoparticles (proticles) have been successfully used to deliver compounds across the blood brain barrier (page 302 left column). Kratzer teaches that protamine is known to condense DNA into compact particles and teaches that proticles are easy to produce and have low cytotoxicity compared to cationic liposomes (page 302 left column). Kratzer teaches formation of the proticles by self-assembly of oligonucleotides in various concentrations of protamine and then the proticles were incubated with apolipoproteins to coat the proticles (page 302 section 2.2.1). Kratzer teaches that the oligonucleotide/protamine ratio affected uptake efficiency and transcytosis where higher oligonucleotide/protamine ratio had higher uptake and transcytosis than proticles with lower protamine content (page 305 section 3.3, figure 3). Kratzer teaches the proticles were incubated with apolipoproteins A-I and that particle size and aggregation was dependent on the Apo concentration (page 306-307 section 3.4). Kratzer teaches that proticles with apoA-I coatings had significantly enhanced transcytosis across brain cells (page 310 left column).
Phua teaches catalase integrated hyaluronic acid as a nanocarrier for enhanced photodynamic therapy in solid tumor (title). Phua teaches that photodynamic therapy (PDT) is a cancer treatment involving light illumination at the tumor site for inhibition of tumor growth (page 4742 left column). Phua teaches that the efficacy of PDT is limited by the lack of endogenous oxygen in tumors (page 4742 right column). Phua teaches that catalase is an enzyme that is used for the in situ generation of oxygen through conversion of hydrogen peroxide (page 4743 left column). Phua teaches that production of oxygen could ameliorate tumor hypoxia, leading to better PDT efficacy (page 4743 left column). Phua teaches that hyaluronic acid is known to target the overly expressed CD44 receptors in tumors and that hyaluronic acid is highly amenable to chemical functionalization and that it is known as a therapeutic carrier with covalently attached photosensitizers for targeted therapy (page 4743 right column). Phua teaches a system comprising hyaluronic acid, catalase and a chlorin e6 photosensitizer where the catalase is conjugated to the hyaluronic acid to form nanoparticles (page 4743 right column). The integration of hyaluronic acid with catalase improves the stability of the system in the presence of proteases and enables active targeting to tumors (page 4743 right column). Phua teaches that the ratio of photosensitizer and catalase is tunable and predictable and provides examples where cell viability varied with the amount of catalase (page 4743 into 4744, Figure 2d-e). Catalase has a molecular weight of 250 kDa and an isoelectric point of 5.4 as evidenced by the instant specification [0018].
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a nanostructured high density lipoprotein comprising apolipoprotein E, DMPC, DOPA, hyaluronic acid, protamine and catalase and a photosensitizer. Lipoproteins comprising DMPC, DOPA and apolipoprotein E are known from Huang and coating lipoproteins with hyaluronic acid to avoid liver accumulation is known from Liu and the use of protamine to condense oligonucleotides to form particles encapsulated by apolipoproteins is known from Kratzer. It would have been desirable to one of ordinary skill to use hyaluronic acid with the lipoproteins of Huang in order to avoid unwanted drug accumulation in the liver and one would have had a reasonable expectation of success in incorporating hyaluronic acid as it has been successfully demonstrated with lipoproteins by Liu. The lipoproteins of Huang have siRNA loaded in a calcium phosphate core particle and it is known that oligonucleotides may alternatively be condensed into particles with protamine rendering it an obvious alternative for forming core oligonucleotide drug structures to one of ordinary skill. One would have a reasonable expectation of success as protamine oligonucleotides have been successfully demonstrated by Kratzer for use with apolipoprotein coating and for passing the blood brain barrier. Regarding catalase, it is known from Phua that catalase may be conjugated to hyaluronic acid to target tumors and to include a photosensitizer for photodynamic therapy in treating tumors. The nanostructure obvious over Huang, Liu and Kratzer is known for treating tumors such as glioblastomas and includes hyaluronic acid and it would be obvious to further include catalase as an additional means of treating tumors. It is prima facie obvious to combine compositions suitable for the same purpose to form a composition to be used for the very same purpose of treating tumors, the idea of combining them flows logically from them having been individually taught in the prior art for their tumor treatment properties. One would have a reasonable expectation of success as the catalase particles of Phua rely on hyaluronic acid which is already obvious to include in the nanostructures. Regarding the zeta potential of claim 33, zeta potentials of -25.66 ± 0.65 are known from Liu for particles, rendering this an obvious zeta potential for one of ordinary skill to construct the particles to.
Further, in view of the teachings of Huang, Liu, Kratzer and Phua that the amount of the components may be varied and that the amount of different components has varying effects on the resulting nanostructures, the amount of the apolipoprotein, DMPC, DOPA, hyaluronic acid protamine and catalase components to include in the nanostructures is an art-recognized result effective variable such that determining that the apolipoprotein is 2.5-40%, the lipid component is 35-95%, the hyaluronic acid is 0.03-15%, the protamine is 0.1-20%, the total of hyaluronic acid and protamine is 0.03-15% and the protein drug (catalase) is 1-43% would be a matter of optimization through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is known from Huang that glioblastoma uptake was related to the ApoE concentration and the DMPC concentration. It is additionally known from Kratzer that the oligonucleotide/protamine ratio affects the uptake and transcytosis and that particle size and aggregation are related to the apolipoprotein concentration. Thus, it is obvious that the amount of each component, including the DMPC and DOPA lipids, hyaluronic acid, protamine and apolipoprotein present in the nanostructures would be determined through routine experimentation in order to optimize the complex for size and uptake in order to achieve the desired drug delivery capabilities. It is known from Phua that the amount of catalase may be varied and it is known that the resulting cell viability varies with the concentration of catalase and thus it would be obvious to optimize the percentage of catalase in the nanostructure in order to achieve the desired effect on tumors treated. Absent evidence to the contrary, the percentage limitations for each component are understood to be achievable through routine experimentation as part of a process of achieving a nanocomplex with optimal drug delivery capabilities.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 28 Apr 2026 have been fully considered but they are not persuasive. Applicant states that the claimed nanocomplex has a specific amount of a protein drug, hyaluronic acid, protamine and a recombinant lipoprotein that provides a general-type carrier for protein drugs having different physicochemical properties (a and b of pages 24-25 of remarks). Applicant states that the nanocomplex of the present application offers various benefits related to optical density values, intracellular enzyme activity, inhibiting membrane damage, delivery of protein, and improved spatial learning (c-g of page 25 of remarks). Applicant argues that Huang, Liu and Kratzer do no disclose delivery of a protein drug with specific structures and that one wouldn’t think of combining a protein drug due to potential side effects (pages 25-26 of remarks). The examiner does not find this persuasive as the teachings of Phua render it obvious to include the protein catalase due to its known association with particles for cancer therapy. Applicant argues that the specific composition of the claimed core-shell structure is different from the applied art (page 26 of remarks). This is not persuasive and the examiner notes that the claims do not require any specific core-shell structure where the components are in precise locations of the complex but instead the claims merely require a “nanocomplex.”
Applicant argues that the art does not disclose the specific content ranges of each component or achieving highly efficient intracellular delivery of the protein drug (pages 27-29 of remarks). This is not persuasive as it is obvious to include each of the required components and the amounts of the components for the complex would be obvious to adjust and optimize for one of ordinary skill in the art. For example, it is known from Huang that glioblastoma uptake is related to ApoE concentration and the DMPC concentration and it is known from Kratzer that the oligonucleotide/protamine ratio affects the uptake and transcytosis and that particle size and aggregation are related to the apolipoprotein concentration. Thus, it is obvious that the amount of each component, including the lipids, hyaluronic acid, protamine and apolipoprotein present in the nanostructures would be determined through routine experimentation in order to optimize the complex for size and uptake in order to achieve the desired drug delivery capabilities. Further, it is known from Phua that the amount of catalase may be varied and it is known that the resulting cell viability varies with the concentration of catalase and thus it would be obvious to optimize the percentage of catalase in the nanostructure in order to achieve the desired effect on tumors treated. Regarding the efficient protein delivery advanced by the applicant, the examiner notes that protein delivery is an intended use of the composition that does not distinguish the claims from the prior art. The claims require a nanocomplex with certain components are certain percentages and these limitations are met from the prior art. The applicant points to Table 11 to indicate improved enzyme activity with protamine and hyaluronic acid at levels as in the claims (page 27 of remarks). This is not persuasive as it is known that the amount of different components included in the obvious complex will have varying results on the performance of the complex and it would be obvious to optimize amounts for desired results, as described above. As far at the applicant may be arguing for unexpected results with the data, the examiner notes that the results pointed to are not commensurate in scope with the claims (e.g. the claims are much broader than is exemplified in the 2-3 formulations tested) and the applicant has not demonstrated that the results are truly unexpected across the claimed range (e.g. the few data points in Table 11 do not adequately indicate that the improved activity levels would be expected from 0.03-15% hyaluronic acid, 0.1-20% protamine, and 0.03-15% of combined hyaluronic acid and protamine).
Applicant argues that the teachings of Phua only involve covalent coupling between catalase and hyaluronic acid and not to a core-shell structure whereas the teachings of Huang, Liu and Kratzer are directed to core-shell structures (page 29 of remarks). The examiner does not find this persuasive. The examiner first notes again that the claims do not require any core-shell structure with components in specific locations of the complex. Further, it is obvious to include catalase for its known compatibility with hyaluronic acid and its known association with cancer therapy. There is nothing to indicate that the catalase of Phua would be incompatible with the particles of Huang, Liu and Kratzer. The examiner notes that “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. Each of the components of the claims are known in the art and their combination is obvious for their benefits they provide and similar uses such as cancer treatment, as detailed in the rejection.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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