DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 76-94 are pending and under examination.
Priority
This application is a CON of 17/208,504, filed 03/22/2021 PAT 12,065,648 which is a CON of 15/755,777, filed 02/27/2018 PAT 10,988,765 which is a 371 of PCT/US2016/049255, filed 08/29/2016 which claims benefit of 62/210,685, filed 08/27/2015 as reflected by the most recent filing receipt.
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 76-82,84 and 89-94 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Regarding Step 1 of the Eligibility Analysis for 35 USC 101, claims 76-82,84 and 89-94 recite a composition and therefore are directed to a product, which is one of the statutory categories of invention.
Regarding Step 2A Prong One of the Eligibility Analysis, claims 76-82,84 and 89-94 recite at least one judicial exception that is a product of nature, which is a microorganism selected from Kocuria rhizophila, Kocuria kristinae, Kocuria marina, Alcaligenes spp., or Paenibacillus spp. or a component thereof. Based on the broadest reasonable interpretation, the preamble recites “composition” and the body of the claim only recites specific microorganisms or a component thereof, and therefore claims 76-82,84 and 89-94 are claiming the recited microorganisms themselves which are products of nature. Claim 77 recites that the microorganism is viable and is therefore, still a product of nature. Claim 79 cites further comprising a pharmaceutically acceptable carrier and based on the BRI the carrier may be water and is still a product of nature. Regarding claim 82 wherein the at least one microorganism is lyophilized, the microorganism would still not have markedly different characteristics as if a lyophilized microorganism was placed back in water it would no longer be lyophilized. Claims 76-82,84 and 89-94 do not have markedly different characteristics from the recited microorganisms as found in nature.
Next then, Step 2A Prong Two is analyzed to determine if the claim recites additional elements that integrate the judicial exception into a practical application. Regarding claims 76-78,80-82,84 and 89-94, no additional elements are recited. Regarding claim 79, an additional ingredient which is a pharmaceutically acceptable carrier is recited, but reads on the carrier being water and therefore does not integrate the judicial exception into a practical application. Claims 85-88 recite additional elements (a pharmaceutical compound that induces a detoxification response, and an inhibitor of a daf-22 gene or its human homolog, SCPx) and therefore recite additional elements that integrate the judicial exception into a practical application and therefore claims 85-88 are not included in the rejection.
Next, Step 2B of the Eligibility Analysis on whether a claim amounts to significantly more than the judicial exception is evaluated. Claims 76-78,80-82,84 and 89-94 do not include any additional elements in addition to the recited at least one microorganism. With respect to instant claim 79, although the limitations in this claim indicate that the microorganism is in a composition comprising a pharmaceutically acceptable carrier, the BRI of this encompasses the microorganism in water. Merely reciting a generic “composition” thus fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. The claims do not add significantly more because generally linking the use of the judicial exception to a particular technological environment or field of use. See MPEP 2106.05(h).
Therefore, it is concluded that claims 76-82,84 and 89-94 fail all of the steps of the test for subject matter eligibility under 35 USC 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.
Claims 84 and 88 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.
Claim 84 recites “wherein the at least one microorganism or component thereof is formulated for co-administration with a drug that provokes a detoxification response”. As this is a product claim and recites a wherein clause and uses the language “is formulated for co-administration…”, it is not clear based on the wording if the composition is merely capable of being formulated for co-administration with a drug that provokes a detoxification response or if the drug is required to be there. Therefore, the metes and bounds of the claim are unclear.
Claim 88 recites "wherein the inhibitor is or comprises". In this case, “is” is interpreted as equating to “consisting of” and does not limit additional ingredients or components from being present in the composition, but it limits the scope of the inhibitor such that additional nucleotides, nucleotide modifications or functional groups on the inhibitors would be excluded. The metes and bounds of the claim are not clear because it is not clear if additional components or ingredients can be included in the inhibitor because "comprising" would allow additional components but "is" would not.
Claim 88 also lists “morpholino” as an inhibitor. However, this is not clear as to whether morpholino is referring to a small molecule morpholino compound, or if it is a morpholino oligonucleotide. There is no definition in the instant specification, and it is noted that paragraph 00183 of the instant specification lists small organic molecule libraries which include morpholino compounds. Moulton (Current Protocols in Nucleic Acid Chemistry, 2006; 4.30.1-4.30.24) taught that morpholino oligos (Morpholinos) are synthetic uncharged P-chiral analogs of nucleic acids, and the morpholino phosphorodiamidate backbone of Morpholinos consists of morpholine rings that bear methylene groups and are bound through modified phosphates in which the anionic oxygen is replaced by a nonionic dimethylamino group, and that antisense morpholinos block the interactions of macromolecules with mRNA by base pairing with the targeted mRNA in a complementary fashion (page 1). Therefore, without an explanation, it is not clear if the “morpholino” recited in claim 88 is a small molecule, which would be reasonable based on paragraph 00183 of the instant specification, or could be reasonably interpreted as a morpholino oligonucleotide which is known in the art a shown by Moulton, and since the recitation is included in a list with other nucleotide based inhibitors. Therefore, the metes and bounds of what “morpholino” is are not clear.
Written Description Rejection
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 76-94 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 76,77 and 79-94 encompass a composition comprising at least one of the recited microorganisms, or a genus of a component thereof, wherein the composition is for attenuating a detoxification response induced by a translation defect and/or treating related symptoms in a subject in need of such treatment. Therefore, the claims encompass a genus of components from at least one of the recited microorganisms that performs the recited function of attenuating a detoxification response induced by a genus of translation defects and/or treating a genus of symptoms in a subject in need of treatment. Claim 78 encompasses that the component thereof is a secreted factor, but still encompasses a genus of secreted factors that perform the function. Claim 81 recites “wherein the microorganism or component thereof is formulated in an amount sufficient” to perform the recited functions. Claims 87-88 also encompass a large genus of inhibitors of a daf-22 gene or its human homolog, SCPx.
Regarding the state of the art, there is a lack of teaching in the art regarding the components of the recited microorganisms that would result in the recited functions as being carried out, as well as what an amount sufficient of the microorganism or component thereof would be to result in improving the efficacy of a drug that provokes a detoxification response or in an amount sufficient to reduce toxicity of a co-administered pharmaceutical compound, or in an amount sufficient to increase the tolerable therapeutic dosage of a drug that provokes a detoxification response, as well as a core structure of daf-22 or SCPx inhibitors.
The instant specification discloses that the term 'components thereof' as used herein refers to microbial components such proteins, nucleic acid, cell surface components, microbial polysaccharide, secreted toxins, endotoxins, cell wall, cell membrane, capsules and the like (paragraph 00179). However, the specification does not show the required structure-function correlation that would result in a component of the recited microorganisms as being able to carry out the recited function of attenuating a detoxification response induced by a translation defect and/or treating related symptoms in a subject in need of such treatment.
The specification does not specify what the “amount sufficient” is that performs the functions recited in claim 81 to provide written description for the genus of sufficient amounts.
Regarding claims 87 and 88, the specification generically discloses an inhibitor is a nucleic acid and mentions antisense oligonucleotide, single-stranded, double-stranded, RNAi, miRNA or siRNA (paragraph 0180-00181). The specification states that the effect of an inhibitor on the expression of one or more genes can be determined by utilizing assays well known to one of skill in the art or provided by the present invention to assess the specificity of a particular compound’s effect on the expression of a target gene (paragraph 00188). However, this does not provide written support for the genus of inhibitors of the recited genes in claims 87 and 88 which could be any small molecule compound and encompasses a genus of oligonucleotide based inhibitors.
Example 1 largely focus on identifying genetic pathways that mediate translation inhibition induced xenobiotic defense response (page 64), a genome wide RNAi screen of each worm gene (page 65). Example 2 pertains to inactivation of C. elegans translation components by feeding the animals E. coli expressing specific dsRNAs targeting translation factor mRNAs induces the expression of xenobiotic detoxification genes, bacterial pathogen response genes (page 66) and how translation inhibition of different genes induces xenobiotic detoxification genes (pages 67-72). Example 3 pertains to a genome wide screen for gene inactivations that render animals unresponsive to translation inhibition reveals a bile acid biosynthetic pathway. Page 110 discloses that a collection of bacterial were screened for disruption of intestinal pgp-5::gfp induction by a germline translation mutation, and three bacterial strains out of 40 tested strongly suppressed the induction of pgp-5::gfp including Kocuria rhizophila, Alcaligenes spp., and Paenibacillus spp. (Fig. 5A,B and 10C) and Kocuria rhizophila suppresses detoxification responses (Fig. 5C and D).
Therefore, the specification discloses microorganisms including Kocuria rhizophila, Alcaligenes spp., and Paenibacillus spp. that suppressed the induction of pgp-5::gfp and that Kocuria rhizophila suppresses detoxification responses which meet the written description and enablement provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. However, claim(s) 76-94 are directed to encompass a genus of components of the recited microorganisms, a genus of an amount sufficient in claim 81 and a genus inhibitors of a daf-22 gene or its human homolog, SCPx, which perform the recited functions and which only correspond in some undefined way to the specifically instantly disclosed species, and which do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claims.
Note: MPEP 2163 which states for each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In the instant case, no species of the components of the recited microorganisms have been shown to perform the recited functions. No species of what is a sufficient amount to perform the recited functions of claim 81 have been disclosed, and no species of inhibitors of daf-22 gene or its human homolog, SCPx have been disclosed.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed microorganisms themselves (Kocuria rhizophila, Alcaligenes spp., and Paenibacillus spp.), the skilled artisan cannot envision the detailed chemical structure of the encompassed components of the microorganisms thereof that attenuate a detoxification response induced by a translation defect and/or treating related symptoms in a subject in need of treatment, and cannot envision what the “amount sufficient” that the microorganism or component thereof is formulated in to carry out the functional limitations, and cannot envision the detailed chemical structure of the encompassed inhibitors of the daf-22 gene or its human homolog SCPx. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
Therefore, the full breadth of the claim(s) do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Interpretation
The instant claims are drawn to a product/composition, however they recite intended uses and wherein clauses. Therefore, regarding claims 76,80,84 and 89-94 the wherein clauses which do not further limit the structure of the product has little patentable weight and the intended use is not given patentable weight. Art that teaches the structure of the product recited in the claims reads on the claims, regardless of the intended use recited in the instant claims or the use recited in the art, and regardless of the wherein statements that do not pertain to the structure of the composition.
See MPEP 2112.01: "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In addition, "the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). Note: MPEP 2111.02.
Regarding claim 78, “the component thereof” is not required in this claim as it depends from claim 76 which recites “or a component thereof”, and claim 78 is not requiring the component thereof to be present. Therefore, the component thereof which is a secreted factor is not a required claim limitation.
Regarding claim 84, the claim is being interpreted as not requiring the drug and is just capable of being formulated for co-administration with the recited drug.
Claim Rejections - 35 USC § 102
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.
Claims 76-78,84 and 89-94 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moissenet et al. (Journal of Clinical Microbiology, Vol. 50, Issue 4, April 2012).
Regarding claims 76-78,84 and 89-94, Moissenet et al. teach blood infected with Kocuria rhizophila (Abstract and page 1495). As the blood is infected with the microorganism, the microorganism would be viable. See claim interpretation above regarding the intended use and wherein clauses.
Therefore, Moissenet et al. teach all of the limitations of claims 76-78,84 and 89-94.
Claims 76-80,84 and 89-94 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yousef et al. (US 20110245152, Pub. 6 Oct. 2011).
Regarding claims 76-78,84 and 89-94, Yousef et al. teach a bacterial composition containing the Paenibacillus polymyxa strain OSY-DF, a fermentate or crude extract of a live culture of Paenibacillus polymyxa, strain OSY-DF, or a live culture of a bioactive mutant thereof. See claim interpretation above regarding the intended uses and wherein clauses.
Regarding claim 79, Yousef et al. teach the composition of the present invention may be used in a pharmaceutical preparation, and the compositions can be provided in combination with a pharmaceutically acceptable carrier (paragraphs 0115-0117).
Regarding claim 80, Yousef et al. teach a probiotic composition containing a live culture of Paenibacillus polymyxa OSY-DF or its bioactive mutants, or a fermentate of such live cultures. Such probiotic preparations may be sufficiently stable such that the microorganisms are still live or dormant in the compositions at the time of ingestion by a subject, thereby maintaining activity of the microorganism (paragraph 0126), and the probiotic composition may be of any form that is orally administrable (paragraph 0129).
Claims 76,78-80,82,84 and 89-94 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nieuwdorp et al. (US 20140294774, Pub. 2 Oct. 2014).
Regarding claims 76,78,84 and 89-94, Nieuwdorp et al. teach a pharmaceutical, food, or feed composition comprising Eubacterium hallii et rel. and/or Alcaligenes faecalis et rel. (paragraph 0007).
Regarding claim 79, Nieuwdorp et al. teach the disclosure pertains to a pharmaceutical, food, or feed composition comprising Alcaligenes faecalis et rel., optionally for use as a medicament. Such composition may comprise a carrier, such as an inert carrier (paragraph 0022) and a pharmaceutical composition will usually comprise a carrier, such as a pharmaceutical carrier, in addition to bacteria of the taxon Eubacterium hallii et rel. and/or bacteria of the taxon Alcaligenes faecalis et rel. (paragraph 0024).
Regarding claim 80, Nieuwdorp et al. teach the composition referred to herein is for enteral or oral administration (paragraph 0023).
Regarding claim 82, Nieuwdorp et al. teach a composition in solid forms, e.g., a powder of lyophilized bacteria of the taxon Eubacterium hallii et rel. and/or bacteria of the taxon Alcaligenes faecalis et rel. (paragraph 0024).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Nieuwdorp et al. as applied to claims 76,78-80,82,84 and 89-94 above, and further in view of the English translation of Park et al. (JP2004073178A, Published 11 March 2004).
The teachings of Nieuwdorp et al. as applicable to claims 76,78-80,82,84 and 89-94 have been described above.
While Nieuwdorp et al. teach the composition is for enteral or oral administration (paragraph 0023), Nieuwdorp et al. does not teach an enteric coating.
Before the effective filing date, Park et al. taught pharmaceutical compositions and food compositions comprising microorganisms for treating obesity and diabetes which have excellent intestinal viability and produces polysaccharides in the intestine with high efficiency (Field of the invention, page 1). Park et al. taught dietary fiber is recognized as the most useful preparation for obesity prevention and treatment because it is a natural substance without damaging the metabolic balance of the human body and conventional microbial dietary fibers include: Gluconobacter sp…..Alcaligenes…” (page 1 bottom). Park et al. taught the composition of the present invention may be produced as an enteric coating preparation using a method known in the art, such that after passing through the gastrointestinal tract, it reaches the small intestine and the active ingredient microorganisms are rapidly released into the intestine ….. The preparation of the present invention is particularly an oral unit dosage form and can be provided as an enteric-coated enteric preparation. The “enteric coating” herein is pharmaceutically acceptable that allows the coating to be maintained without being degraded by gastric acid, but is sufficiently degraded in the small intestine so that its active ingredient can be released into the small intestine” (pages 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date, to modify the composition comprising Alcaligenes faecalis et rel. of Nieuwdorp et al. to comprise an enteric coating based on the teachings of Park et al. with a reasonable expectation of success. There would be a reasonable expectation of success because both Nieuwdorp et al. and Park et al. pertain to pharmaceutical or food compositions containing microorganisms, including Alcaligenes. One of ordinary skill in the art would have been motivated to do so because Park et al. teach the benefits of enteric coatings as such that after passing through the gastrointestinal tract, it reaches the small intestine and the active ingredient microorganisms are rapidly released into the intestine and Park et al. taught pharmaceutical compositions and food compositions comprising microorganisms for treating obesity and diabetes which have excellent intestinal viability and produces polysaccharides in the intestine with high efficiency.
Accordingly, the limitations of claim 83 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
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 76-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,065,648.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of Patent ‘648 recite a method of administering a pharmaceutical compound that induces a detoxification response in a subject in need of treatment by said pharmaceutical compound comprising co-administering to the subject said pharmaceutical compound and an inhibitor of expression of a daf-22 gene or its human homolog, SCPx, wherein administering the pharmaceutical compound with the inhibitor increases the bioavailability of the pharmaceutical compound. Claim 6 of Patent ‘648 recites the inhibitor is or comprises a microorganism or component thereof, small molecule, siRNA, shRNA, double-stranded RNA, microRNA, aptamers, morpholinos, single-stranded oligonucleotides or antisense oligonucleotide, and claim 17 recites the microorganism is Kocuria rhizphila.
Therefore, the composition used in the method of Patent ‘648 can comprise the same microorganism or component thereof that is recited in instant claim 76, and lists the same inhibitors of the daf-22 gene or SCPx homolog as claimed in instant claims 87-88. As the instant claims recite “a composition comprising” additional components may be included in the composition. Therefore, the instant claims and the claims of Patent ‘648 are not patentably distinct.
Conclusion
Claims 76-94 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE L SULLIVAN whose telephone number is (703)756-4671. The examiner can normally be reached Monday-Friday, 7:30-3:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram R Shukla can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE L SULLIVAN/Examiner, Art Unit 1635
/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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