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 7-9, 15-19, 21, 22, 27-29, 33 and 35-100 are cancelled.
Claims 1-6, 10-14, 23-26, 30-32 and 34 are pending and presented for examination on the merits.
Priority
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Applicant has not filed an Information Disclosure Statement. Applicant is reminded of their duty to disclose information material to patentability (see 37 CFR § 1.56). § 1.56 Duty to disclose information material to patentability. (a) (in part) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.
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.
Claim 26 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treatment of a disease or disorder in a subject does not reasonably provide enablement for prevention of any disease or disorder in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without an undue amount of experimentation.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation. While all of the factors have been considered, only those required for a prima facie case are set forth below.
1) Scope or breadth of the claims
The claims are broader in scope than the enabling disclosure. The specification merely discloses, without more, delivery of an antibiotic to infected macrophages and Staphylococcus aureus biofilms (Examples 1 and 2). However, Applicant is purporting to prevent any and all diseases and conditions in a subject, which includes genetic diseases.
2) Nature of the invention
The nature of the invention is directed a method for preventing a disease or disorder in a subject by administering a dry composition of a polysaccharide and lipid droplets.
3) Relative level of skill possessed by one of ordinary skill in the art
MPEP 2141.03 states (in part), “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[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 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988)
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II).
4) State of, or the amount of knowledge in, the prior art
The art (Gina Hagler [online] retrieved on 7/18/26 from: https://www.americangene.com/blog/rare-diseases-why-are-they-difficult-to-cure/; 2020; 6 pages) teaches that it is difficult to find rare disease cures (Page 1) and that there is no cure for phenylketonuria, cystic fibrosis, hemophilia A and muscular dystrophy (Pages 4-5). If there is no cure, then these diseases cannot be prevented.
5) Level or degree of predictability, or a lack thereof, in the art
The medical arts involve physiological reactions which are inherently unpredictable. MPEP 2164.03: “In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”
6) Amount of guidance or direction provided by the inventor
Applicant was required to provide in the specification additional guidance and direction with respect to how use the claimed subject matter in order for the application to be enabled with respect to the full scope of the claimed invention. Although the instant specification discloses treatment of infected macrophages and Staphylococcus aureus biofilms it remains silent on prevention of any and all diseases and conditions.
7) Presence or absence of working examples
The specification fails to provide scientific data and working embodiments with respect to prevention of any and all diseases and conditions.
8) Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure
In order to actually achieve the claimed invention, it is clear from the discussion above that the skilled artisan could not rely upon Applicant's disclosure as required by 35 U.S.C. 112, first paragraph, and would have no alternative recourse but the impermissible burden of undue experimentation in order to practice the full scope of the embodiments presently claimed. One of ordinary skill in the art would have to conduct a myriad number of experiments comprising testing against any and all diseases and conditions in a subject including inherited genetic diseases to see if the method prevented any of them with no likelihood of success. Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which conditions and diseases, if any, can be prevented by administering the claimed composition with no assurance of success.
Genetech, 108 F.3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” (Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997)).
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.
Claim(s) 1-4, 10-14 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanchez et al. (Journal of Food Engineering 2015;167:99-105) as evidenced by Petraru et al. (Plants 2021, 10, 2487: 22 pages).
Regarding claims 1-4, Sanchez et al. disclose spray dried particles of encapsulated sunflower oil droplets with a dietary polysaccharide inulin wall and a droplet size of around 2 µm and a spray dried particle fine powder size of < 22 µm (Abstract), hence a dry composition. Sunflower oil is composed of lipids (See the abstract of and Table 1 of Petraru et al. teaching that sunflower oilseeds are rich in lipids). Since the inulin is dissolved in an aqueous phase (Page 100, 2.2.1. Protocol 1 and 2.2.2. Protocol 2), then it meets the limitation of “the polysaccharide is not in a nano-particulate form” because the specification teaches that it means that the polysaccharide remains in an aqueous form, rather than in the form of a nanoparticle, prior to a spray drying process. (Specification [0105]).
Regarding claims 10-14, Sanchez et al. disclose α-tocopherol as a model oil for lipophilic compounds for encapsulation (Page 100, 2.1. Materials), where α-tocopherol is naturally anti-inflammatory and poorly water-soluble drug/pharmaceutical agent dissolved in the liquid droplets and thus contained in the lipid droplets.
Regarding claim 20, Sanchez et al. disclose the emulsifier Tween 20, which is an excipient/stabilizer (Abstract).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6, 10-14, 23-26, 30-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Nik et al. (WO2020154614) as evidenced by Petraru et al. (Plants 2021, 10, 2487: 22 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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The limitation of “the polysaccharide is not in a nano-particulate form” means that the polysaccharide remains in an aqueous form, rather than in the form of a nanoparticle, prior to a spray drying process. (Specification [0105]).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical active substance delivery research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from drug delivery formulation components, formulation methods and techniques, such as for microencapsulation, and treatment methods— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-5, Nik et al. teach an encapsulation particle comprising an active material and a matrix material comprising potato protein and dietary polysaccharide inulin or vegetable fiber, which includes cellulose, or combination carrier (Claims 10 and 12; [0041], Table 1, [0066]), where the inulin is used as wall material [0069], and where the protein diffuse into the oil-water interface and create strong interfacial film around oil droplets and prevent droplet aggregation [0058], where the carrier can be present from 1% to 99% by weight of the encapsulation particle (Claim 11). Nik et al. also teach methods for producing an encapsulation particle from an oil-in-water emulsion that includes drying (Claim 17), which requires the presence of an oil and produces a dry product. Nik et al. teach oil droplets having a diameter of 0.1 to 20 microns and in an amount of 0.1 to 60% by weight (Claims 1-3 and 7) and include medium chain triglycerides [0032], which are lipids, and exemplify oleic acid rich sunflower oil [0045, 0057, 0063, 0069], which is composed of lipids (See the abstract of and Table 1 of Petraru et al. teaching that sunflower oilseeds are rich in lipids). The polysaccharide inulin does not appear to be in a nano-particulate form as defined by the specification. Nik et al. expressly teach: “Active materials in an oil phase are preferably encapsulated within a matrix composed of unhydrolyzed potato protein and a carrier.” [0040].
Regarding claims 10-14, Nik et al. teach an active material of an antimicrobial agents, anti-inflammatory agents and analgesics, which are pharmaceutical agents. It is the Examiner’s positions that disclosure of analgesics renders obvious opioid analgesics such as morphine, oxycodone and fentanyl, which are considered to have psychotropic effects. Nik et al. teach that the active material is oil-based and the oil droplets are composed of an active material [0015, 0040], thus indicating that the active material can dissolve in the liquid droplets and since they are oil/lipid soluble, then they are poorly water soluble drugs.
Regarding claim 20, Nik et al. teach adding additional components such as a second emulsifier and/or antioxidant ([0039]; claim 16), which are excipients/stabilizers.
Regarding claims 23-24, these are product-by-process claims. Please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” See MPEP 2113 Product-by-Process Claims [R-08.2017] I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 25, Nik et al. teach an example with a mean diameter of approximately 0.7 microns [0076] and 0.65 microns [0077], which is less than 15 microns, and claim an oil droplet diameter of 0.1 to 20 microns (Claim 3), which would appear to embrace the claimed average diameter of < 15 µm. Nik et al. also teach encapsulation particle diameter sizes of 0.2 microns (200 nm) and that the particles sizes may vary dependent on the method of production [0040]. Thus, it appears to be merely routine optimization to achieve microparticles with an average diameter of < 15 µm.
Regarding claim 34, Nik et al. teach methods for producing an encapsulated particle comprising emulsifying an active material, potato protein and a carrier, which is taught to be for example the polysaccharide inulin, to obtain an oil-in-water emulsion (Claim 17) and the emulsion is dried by spray-drying (Claim 20). Nik et al. teach that the inulin carrier material is dissolved in an aqueous solution [0048]. Nik et al. teach that the emulsion has oil droplets of 0.1 micron to 20 micron diameter (Claim 2) where 0.1 microns is 100 nm, thus including nano-sized particles in the emulsion to make a nano-emulsion comprising lipid droplets and the polysaccharide inulin.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Nik et al. is that Nik et al. do not expressly teach wherein the polysaccharide is not in a nano-particulate form. However, Nik et al. teach that the inulin is dissolved in the aqueous solution [0048], and thus meets the instant specifications definition for this limitation (Specification [0105]).
2. The difference between the instant application and Nik et al. is that Nik et al. do not expressly teach wherein the ratio of polysaccharide to lipid in the composition ranges from about 10:90 to about 90:10. However, Nik et al. do teach the amount of oil (Claim 3), the amount of protein (Claim 4) and the amount of carrier inulin (Claim 11). It is then merely routine optimization to arrive at the ratio of polysaccharide to lipid in the composition ranges from about 10:90 to about 90:10. See MPEP 2144.05 (II) (A): “[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)…see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
3. The difference between the instant application and Nik et al. is that Nik et al. do not expressly teach a method for improving the health of a subject or for treating a disease or disorder in a subject or for treating or preventing a microbial infection in a subject such as a bacterial infection due to Staphylococcus aureus and bacterial infection biofilm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the encapsulated particles of Nik et al. and administer it to a subject to improve the health of a subject or to treat a disease or disorder in a subject or to treat or prevent a microbial infection in a subject such as a bacterial infection due to Staphylococcus aureus and bacterial infection biofilm, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because purpose of the compositions of Nik et al. are for human consumption such as a beverage (Examples 7-8, [0075-0077]) and Nik et al. teach adding all sorts of active materials including vitamins (Claims 9 and 13), which naturally improve the health of a subject, as well as antimicrobial active and anti-infections agents (Claims 9 and 13), which implicitly treat and prevent microbial infection in a subject including a bacterial infection due to Staphylococcus aureus and bacterial infection biofilm. Identification of the infectious bacterial species such as Staphylococcus aureus and any biofilm is well within the skill level of the ordinary artisan in this art. Accordingly, the ordinary artisan would have reasonable expectation of success in administering the encapsulation particle emulsion of Nik et al. to treat and prevent the claimed diseases and conditions in a subject in the absence of evidence to the contrary.
Claim 3 is further rejected under 35 U.S.C. 103 as being unpatentable over Nik et al. (WO2020154614) as evidenced by Petraru et al. (Plants 2021, 10, 2487: 22 pages), as applied to claims 1-6, 10-14, 23-26, 30-32 and 34 above, in further view of Edwards et al. (WO2014151326).
Applicant claims:
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The reference of Nik et al. is discussed in detail above and incorporated by reference.
Nik et al. do not expressly teach glucomannan as the polysaccharide. However, Edwards et al. teach that inulin and glucomannan are functionally equivalent hydrocolloids (Claim 5) for use in edible matrices encapsulating substances (Claim 1) such as pharmaceuticals (Claims 11 and 15). Consequently, it is obvious to the ordinary artisan to substitute inulin for glucomannan as the polysaccharide with a reasonable expectation of success. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
Claim 14 is further rejected under 35 U.S.C. 103 as being unpatentable over Nik et al. (WO2020154614) as evidenced by Petraru et al. (Plants 2021, 10, 2487: 22 pages), as applied to claims 1-6, 10-14, 23-26, 30-32 and 34 above, in further view of Quay (US20040077540).
Applicant claims:
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The reference of Nik et al. is discussed in detail above and incorporated by reference.
Nik et al. do not expressly teach that the active substance is an anti-inflammatory agent, an anti-histamine or a cholesteroal-lowering drug. However, the broadest embodiment of Nik et al. includes all active materials [0007]. Quay teaches that biologically active agents are selected from a small molecule drug, a peptide, a protein, and a vaccine agent (Claim 12) and direct the artisan to, for example, anti-inflammatory agents, opioids, antihistamines and antibacterial agents (Claim 13) as well as psychotropic agents and cholesterol-lowing agents (Claim 16). Accordingly, the ordinary artisan would have a reasonable expectation of success in employing an anti-inflammatory agent, an anti-histamine, opioid, psychotropic agent or a cholesteroal-lowering drug in the composition of Nik et al. to improve upon the number of diseases and conditions that it could treat/prevent. “The normal desire of scientists or artisans to improve upon what is already generally known” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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