DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. The claims filed Feb. 5, 2024 have been entered. Claims 1-20 are under consideration in this Office Action.
Priority
3. Applicant’s claim for domestic priority under 35 U.S.C. 119(e) is acknowledged. However, the CIP application, 16/761,961 upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for claims 1-20 of this application. 16/761,961 does not teach the inclusion of soybean protein. At best, the specification of 16/761,961 only refers to Pas. multocida being cultured by using tryptic soy agar medium at paragraph 109. There is no teaching of an oral composition comprising 0.1-50 weight % of soybean protein. Thus, priority cannot be granted to 16/761,961 since what is now claimed, has not been previously recited in the continuation in part application.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on Oct. 27, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
5. Claim 2 is objected to because of the following informalities: Acronyms like DHA and EPA must be spelled out when used for the first time in a chain of claims. Appropriate correction is required.
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.
6. Claims 7-20 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-20 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below:
Claims 1-20 are drawn to an composition comprising: mastic resin solution which concentration is 10-60%, 0.01-1.0 weight % of lactic acid bacterium, and 0.1-50 weight % of soybean protein; wherein said mastic resin solution is made by solving in solvent, and wherein the amount of said mastic resin solution is 0.1-50% for said oral composition.
Naturally occurring mastic resin is an aromatic resin harvested from the Pistacia lentiscus var. Chia tree, predominantly on the island of Chios, Greece. It is produced in the form of small, brittle "tears" that are harvested and hand-cleaned. Mastic has numerous uses, including being used as a natural chewing gum. Naturally occurring lactic acid bacteria (LAB) are ubiquitous in the environment, found on plants, in soil, and within the gastrointestinal and urogenital tracts of animals and humans. These bacteria are responsible for the fermentation process that produces lactic acid, which gives fermented foods like yogurt, sauerkraut, kimchi, and sourdough bread their characteristic tangy flavor and texture. Naturally occurring soybean protein is the main protein in soybeans, which is a complete protein containing all essential amino acids. It's found in many whole soy foods like edamame, tofu, and tempeh, as well as in processed forms such as soy protein concentrate and isolate. Naturally occurring soybean protein is the main protein in soybeans, which is a complete protein containing all essential amino acids. It's found in many whole soy foods like edamame, tofu, and tempeh.
Naturally occurring mastic essential oil is extracted from the resin, leaves, or branches of the Pistacia lentiscus tree, which is native to the Mediterranean. Naturally occurring paraffin originates from crude oil and other fossil fuels like coal. The most prominent natural form is ozokerite, a mineraloid sometimes called "earthwax". Naturally occurring docosahexaenoic acid (DHA) is found primarily in fatty fish like salmon, mackerel, and sardines, as well as in shellfish and algae. It can also be found in smaller amounts in foods like grass-fed meat and dairy, and omega-3-enriched eggs. Naturally occurring eicosapentaenoic acid (EPA) is found primarily in oily fish like salmon, mackerel, herring, and sardines, as well as in fish oil. Microalgae and thraustochytrids are also significant natural sources. Thus, all of the ingredients are therefore not markedly different from their counterparts found in nature.
These claims fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of natural occurring lactic acid bacteria, mastic resin, soybean protein and other naturally occurring components. All the components together as a composition does not change the structure of the individual naturally occurring components.
Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Furthermore, the additional elements in dependent claims such as oil, and stay agents are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections.
If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional steps, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance).
Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1, 6, 11 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 6, 11 and 16 all recite the “…mastic resin solution which concentration is 10-60%,…” but then each claim also recites “…said mastic resin solution is 0.1-50% …“ which is inconsistent with regard to the concentration of the mastic resin solution. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by the different ranges of mastic resin solution. Therefore, clarification is required to overcome the rejection.
B) Claims 5, 10, 15 and 20 fail to further limit the independent claim from which they depend. The rejected claims recite “…wherein said periodontal disease bacterium is Porphyromonas circumdentaria, and wherein said infection disease bacterium is Pasteurella multocida..” However, the recitation does not further limit the composition or preventative composition by adding additional components or narrowing the recited components. Therefore, clarification is required to overcome the rejection.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determ2ining 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.
8. Claims 1, 3-5, 6, 8-10, 11, 13-15, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO2021235512 (published 2021-11-25, priority to 2021-05-20).
The claims are drawn to oral composition and preventative compositions comprising: mastic resin solution which concentration is 10-60%, 0.01-1.0 weight % of lactic acid bacterium, and 0.1-50 weight % of soybean protein and 0.01-1.0 weight % mastic essential oil.
At the outset, it is noted that the preamble for the independent claims recites “…for animal for sterilizing a periodontal disease bacterium and an infection disease bacterium of dog or cat…” or the like and does not further limit the components of the composition. Therefore, Applicants is remined that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Additionally, the claims recite “…wherein said mastic resin solution is made by solving in solvent..” However, Applicants are reminded that a product by process claim is not limited to the manipulations of the recited process steps, only to the structure or components implied by the steps. See MPEP 2113.
WO2021235512 describe an anti-allergy functional food composition, a cosmetic, and a percutaneous external agent containing mastic oil as an active component [abstract]. Mastic is known about as having a sterilization or an anti-microbe effect. The sterilization effect for periodontal disease bacteria regardless of man or animals other than man (e.g. dog, cat), an immunostimulation effect, a prevention of a coating of tongue, and so on, are known [para 16]. Generally, mastic is used by separating three types, which are “mastic sap” , “mastic resin” and “mastic essential oil” [para 16]. The prior art describe an oral composition containing mastic derived components for periodontal disease bacteria of dog or cat [para 17]. The mastic component is selected from any one of mastic powder, mastic oil, mastic essential oil, or mastic water, or wherein said mastic oil is made by solving diluent and is a solution of the diluent of which concentration is 0.1-60 weight % [para 20]. By using the mastic resin and the mastic essential oil and to show the immunosuppression of the mediators especially for man and dog and cat [para 22]. The mastic powder can show the availability for the composition in 0.01%-80%, in preferably 0.1-50% [para 55]. The mastic oil than for combining solid powder like mastic powder. The mastic sap (resin) is used by solving in solvent. The reason for solving the resin in solvent is that the mastic sap (resin) itself is not solved in water and is the result of considering a compatibility with various additive agent when the composition adopts various dosage forms, such as gel, liquid and so on [para 56]. The blending amount of the mastic essential oil is 0.001 to 3% by weight [para 62].
A plant origin unsaturated fatty acid such as soybean oil can be included [para 57]. The composition contains Lactobacillus and lactic acid bacteria producing material as active component improving the immunosuppressive effect of the mastic components [para 68]. It is preferable to incorporate 0.01-1.0% for the whole quantity of the composition [para 70]. When using a natural product containing poly phenol, it can be soybean because it is preferable as having an immunosuppressive effect [para 80]. The binder(s) (thickener(s)) can be soybean oil [para 85]. As the retention agent for retaining the active component in the oral composition, it is possible to use selected from liquid paraffin, gelatinized hydrocarbon which is a mixture of liquid paraffin and polyethylene, vegetable oil, yellow bees wax, and so on and combined use one kind of them or more than two kinds of them. Further, said gelatinized hydrocarbon also plays a role as gelatinizer [para 88].
It is noted that claims 5, 10, 15 and 20 do not further limit the independent claims and are anticipated or found by obvious by WO2021235512.
Regarding the specific concentration of soybean protein listed in the instant claims, MPEP 2144.05 states, "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)."
Therefore, no more than routine would have been required to optimize the amount of soybean protein when WO2021235512 already taught an oral composition and preventative compositions comprising: mastic resin solution which concentration is 10-60%, 0.01-1.0 weight % of lactic acid bacterium, soybean protein and 0.01-1.0 weight % mastic essential oil.
Claim Rejections - 35 USC § 103
9. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over JP2017075098 (published 2017-04-20; priority to 2015-10-13) in view of Terry et al., (US 20170333471 published 2017-22-23; priority to 2016-12-22).
The claims are drawn to oral composition and preventative compositions comprising: mastic resin solution which concentration is 10-60%, 0.01-1.0 weight % of lactic acid bacterium, and 0.1-50 weight % of soybean protein, 0.01-1.0 weight % mastic essential oil, DHA and EPA, and a stay agent.
At the outset, it is noted that the preamble for the independent claims recites “…for animal for sterilizing a periodontal disease bacterium and an infection disease bacterium of dog or cat…” or the like and does not further limit the components of the composition. Therefore, Applicants is remined that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Additionally, the claims recite “…wherein said mastic resin solution is made by solving in solvent..” However, Applicants are reminded that a product by process claim is not limited to the manipulations of the recited process steps, only to the structure or components implied by the steps. See MPEP 2113.
JP2017075098 teach a veterinary composition for animals which shows a bactericidal effect against periodontal disease bacteria, and contains a mastic resin as an active ingredient. The mastic resin is used as a mastic resin solution having a concentration of 5 to 60% [claims]. Thus teaching claims 1, 6, 11 and 16. JP2017075098 describe the pathogen of the infection disease living on dog or cat, for example, Odoribacter denticanis, or the Pasteurella bacterium, such as Pasteurella multocida, Pasteurella dagmatis, Pasteurella stomatis are present [para 7]. In animals, especially pet animals, such as dogs and cats, have dental caries and periodontal disease [para 7]. Depending on living condition, pathogenic bacteria causing periodontal and infection diseases of dogs or cats as with man are Pasteurella bacterium, such as Pasteurella multocida [para 7]. Thus teaching claims 5, 10, 15 and 20. The content of said mastic resin solution is 0.1-50%, or wherein further containing mastic essential oil as an active component, or wherein a content of said mastic essential oil is 0.01-1.0%, or wherein a target animal is dog or cat, or wherein a stay agent is selected from one of the group of liquid paraffin, gelic hydrocarbon that is mixture of liquid paraffin and polyethylene, vegetable oil and yellow bees wax, or wherein stay agents are selected from two or more of the group of liquid paraffin, gelic hydrocarbon that is mixture of liquid paraffin and polyethylene, vegetable oil and yellow bees wax [para 17]. Thus teaching claims 4, 9, 14 and 19. The lactobacillus using for the oral composition for animal of the present invention is lactobacillus [para 37]. The lactobacillus will preferably be incorporated at 0.01-1.0% for the gross quantity of the oral compositions for the said oral composition for animals [para 38]. Thus teaching claims 1, 6, 11 and 16. Furthermore, DHA ((4Z, 7Z, 10Z, 13Z, 16Z, 19Z)-docosa-4,7,10,13,16,19-hexaenoic acid) and/or EPA ((5Z, 8Z, 11Z, 14Z, 17Z)-eicosa-5,8,11,14,17-pentaenoic acid) in the oral composition for animals. DHA and/or EPA are also antibacterial agents against the aforementioned Porphyromonas gulae, Porphyromonas circumdentaria, or Pasteurella multocida, and are effective against gingivitis and it can also be expected to have anti-inflammatory effects related to periodontal disease. Note that the amount of DHA and/or EPA is preferably 0.01 to 50% based on the total amount of the oral composition for animals according to the present invention [para 40]. Thus teaching 2, 7, 12 and 17.
JP2017075098 teach an oral composition and preventative compositions comprising: mastic resin solution which concentration is 10-60 weight %, 0.01-1.0 weight % of lactic acid bacterium, 0.01-1.0 weight % mastic essential oil, DHA and EPA at 0.1-50 weight %, and a stay agent, but does not include a soybean protein.
Terry et al., describe a supplement comprises mastic gum and lecithin. The supplement may also comprise probiotics [abstract]. The animal is orally administered at least once daily with a supplement. The ratio of mastic gum to lecithin is a range from about 1:1, from about 0.5:40.to about 1.5:20 [para 23]. Lecithin may come from many sources, including both plant and animal tissues. Soybeans are the most common source of lecithin [para 18]. So long as the lecithin is capable of being mixed with the mastic gum, it may be in any form [para 20]. Generally, the process typically involves mixing the desired lecithin and mastic gum at ambient conditions to form a substantially homogenous mixture. If other ingredients are desired in the supplement, then in most cases the ingredients may be mixed prior to, simultaneously or even after the lecithin and mastic gum are mixed. In some cases, it may be desirable to add the desired amounts of lecithin and mastic gum to an already commercially available supplement lacking sufficient amounts of lecithin and mastic gum. Once the desired ingredients are mixed, they may be put in the desired form [para 27]. Other ingredients may be added to the supplement so long as the ingredients do not substantially interfere with the desired effects of the supplement comprising mastic gum and lecithin. The supplement may additionally comprise beneficial amounts of probiotics [para 28]. Probiotics that may be useful in the supplement, particularly for equine supplements, include Enterococcus faecium, Lactobacillus acidophilus, Lactobacillus caseii and Lactobacillus plantarum [para 29]. These bacteria are lactic acid bacterium, just as instantly claimed. The amount of probiotic to include in the supplement varies depending upon, among other items, the type of probiotic, other ingredients, and desired results. Typically, an amount of probiotic is measured in colony forming units (CFU's) per dose [para 36].
It is noted that claims 5, 10, 15 and 20 do not further limit the independent claims and are anticipated or found by obvious by WO2021235512.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Terry et al’s soybean protein to JP2017075098’s oral veterinary composition in order to provide supplement used to support a healthy digestive tract in a broad range of animals. One of ordinary skill in the art would have a reasonable expectation of success by incorporating soybean protein because soybean protein is known to be capable of being mixed with the mastic gum, in a substantially homogeneously form, and additionally comprise beneficial amounts of probiotics. Moreover, Terry et al and JP2017075098 teach the combination of these components within an oral composition. Finally it would have been prima facie obvious to combine the invention of JP2017075098 and Terry et al., to advantageously achieve an oral composition or preventative.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take an oral composition and preventative composition comprising: mastic resin solution which concentration is 10-60%, 0.01-1.0 weight % of lactic acid bacterium, and 0.1-50 weight % of soybean protein, 0.01-1.0 weight % mastic essential oil, DHA and EPA, and a stay agent, wherein there is no change in the respective function of the mastic resin solution, nastic essential oil, lactic acid bacterium, soybean protein, DHA and EPA, and a stay agent, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Pertinent Art
10. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See US Patent 9,694,042 teach an oral composition comprising:
mastic resin solution, lactic acid bacterium, and soybean protein.
See JP2012097018, EP2133414 and JP2020062006.
Naqvi et al., (J Am Diet Assoc. 2010 Nov;110(11):1669–1675) teach Polyunsaturated fatty acids (PUFAs) are fatty acids with more than 1 carbon-carbon double bond, including omega 3 (n-3), omega 6 (n-6) and omega 9 (n-9) fatty acids. N-3s from marine sources, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vegetable sources, such as linolenic acid (LNA), which includes alpha-linolenic acid (ALA) and a related n-6 fatty acid, gamma-linolenic acid (GLA), have all been shown to have anti-inflammatory properties.(3-5) Indeed, topical application of bioactive products derived from n-3 fatty acids (including DHA and EPA) confer dramatic protection against inflammation-induced tissue and bone loss associated with periodontitis in experimental models.
Conclusion
11. No claims allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/ Primary Examiner, Art Unit 1645