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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2024 and 07/21/2025 are being considered by the examiner. The signed IDS form is attached with the instant office action.
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 1-18 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 1 recites “a phytonutrient-producer status” and this phrasing is unclear to what the metes and bounds are. Does this mean a specific bacteria, fungi, plant etc. that has the ability to produce phytonutrients? If so, which can be included and which are not included? What is the status and how is it effectively changed? The applicant does not define what this is. The claim also recites the phrase “assessing a level of a preselected phytonutrient or a preselected phytonutrient precursor compound within the subject” and what does this step entail, quantifying or simply determining any amount exists or does not exist, running specific assays to determine this and if so which ones? The claim also recites “comparing a biological concentration and/or excretion amount of a phytonutrient of the subject against commensurate measurements obtained from other subjects”. Although this step may be more straight forward, why is it needed? Comparing one person’s concentration of phytonutrients compared to another is relative and for what end means? The claim then recites “administering a phytofunctional composition to the subject based on the phytonutrient-producer status of the subject” and it is unclear which subject the phytonutrient-producer status is being referred to here. The claim further recites “the active agent being adapted” and it is unclear to the metes and bounds of what needs to occur to adapt the active agent to mediate production of a preselected phytonutrient from the phytonutrient precursor compound in the gastrointestinal tract of the subject? The claim is confusing and indefinite for these reasons.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 102
/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 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. 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 1, 3-4, 6, 9, 11, 13, 16-17, 19-21 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 Francisco TOMÁS BARBERÁN et. al. (From IDS filed on 10/10/2024, WO2014147280A1).
Regarding claims 1, 6, 9, 11, 16-17, 19-21, Barberán discloses microorganisms capable of producing urolithins characterized because: (i) They are selected from biological samples of urolithin-producing individuals, (ii) They are capable of growing in an appropriate culture medium containing ellagic acid and / or elagitannins, (iii) They are capable of producing urolithins when they are incubated in culture medium (ii), for a given and sufficient period of time, under appropriate atmosphere and temperature conditions, (iv) The produced urolithins can be determined by suitable techniques, and because they belong to bacterial species of the Gordonibacter genus selected from Gordonibacter sp. CEBAS 1 / 15P (DSM 26536) or Gordonibacter amelaeae (DSM 19378) (see claim 1).
Barberán discloses “Urolithins are compounds that can be absorbed in the intestine and have biological activity in humans and other mammals (estrogen modulator, anti-inflammatory and anticancer activity, prebiotic effects, cardiovascular prevention, etc.). Urolithins are produced by the gut microbiota from elagitannins and ellagic acid from the diet (Cerdá et al., Agrie. Food Chem., 2005, 53, 5571-5576) that cannot be absorbed unlike urolithins. Among the individuals there is a great variability in urolithin production, being some high, medium, low or null individuals producing these compounds (Cerdá et al., Agrie. Food Chem. 2005, 53, 227-235). Various urolithins (A, B, C, D, M6, M5, M7, isourolithin A) have been described, which differ from each other by the number of hydroxyl groups and their position. Several urolithins (A, B, C and conjugates thereof with glucuronic acid and sulfate) have been identified in biological fluids (urine and blood) and in human and animal organs (rumen of cows, human prostate, mouse prostate, cardiac tissue ...) (Cerdá et al., Eur. J. Nutrition., 2003, 42, 18-28; González-Sarrias et al., Mol. Nut. Food Res., 2010, 54, 31 1 - 322; J. Agrie. Food Chem., 2009, 57, 5623-5632; J. Agrie. Food Chem., 2012. 60, 3068-3077.). This shows that urolithins are absorbed in the intestine by passing into the bloodstream and the various organs exerting a biological effect. Consequently, both the identification and isolation of microorganisms capable of producing urolithins and their use as probiotics, as well as the procedures capable of producing these compounds are of great interest, so there have been different technologies aimed at addressing these issues”.
“Therefore, a specific aspect of the present invention consists of species of the genus Gordonibacter capable of growing in growth media, liquids and solids and in the presence of phenolic compounds in the diet” (see page 6).
Barberán discloses “the food / beverage compositions, dietary supplements, pharmaceutical or probiotic compositions of the present invention that contain a microorganism that has a urolithin production capacity can be employed as a urolithin level enhancer in the organism, blood, intestine (for example, the large intestine), etc., for the purpose of treating, improving, preventing, etc. a variety of diseases and disorders such as arteriosclerosis and other cardiovascular diseases, breast cancer, prostate cancer, inflammatory bowel diseases and premenstrual syndrome. In particular, if food / beverage compositions, dietary supplements, pharmaceutical or probiotic compositions are applied to a human individual who has no urolithin production capacity (non-producer) or a human individual who has a low capacity for urolithin production, A variety of diseases and disorders where urolithins are effective can be prevented in everyday life. In addition, the composition is preferably applied to middle-aged or elderly human subjects, who have a higher risk of suffering from the chronic diseases mentioned” (see page 9, para. 3). This teaching with the broadest reasonable interpretation implies assessing a level of preselected phytonutrient or a preselected phytonutrient precursor compound within the subject as it describes having to identify a human or individual with low or no urolithin production capacity and one would have to assess the levels of the phytonutrient (urolithin) in order to know their status.
Barberán discloses “metabolites produced by Gordonibacter sp. 1: pentahydroxy-urolithin (pentahydroxy-urolithin or urolithin M5), 2: Ellagic acid (ellagic acid). 3: tetrahydroxy-urolithin (tetrahydroxy urolithin or urolithin M6), 4: urolithin C (urolithin C)” (see page 8, figure 1).
Barberán discloses “taking into account that from certain dietary elagitannins ellagic acid is released in the gastrointestinal tract, compounds such as pomegranate punicalagina, elagitannins can be used instead of ellagic acid of nuts, strawberries, raspberries, medicinal plants, as well as plant tissues rich in elagitannins (oak leaf, acorns etc). Alternatively, intermediate metabolites of conversion of ellagic acid to urolithin A can also be used, for example, urolithin M5, urolithin D, etc. This synergistic combination (elagitannins and / or ellagic acid and / or sources thereof, together with the microorganism) provides a more potent urolithin level enhancer. The elagitannins and / or ellagic acid used in the present invention can be either a commercial product or a synthetic product or a natural extract. Alternatively, a natural product containing a large amount of elagitannins or one of its processed products can also be used. Specific examples of products that contain a large amount of elagitannins include pomegranate, nuts, strawberries, chestnuts, blackberries, raspberries, etc.” (see last para. page 9).
Barberán discloses “Preferably, the dose is predetermined to achieve the desired effect according to different modes of use, for example, the target individual and the target diseases and disorders. The daily dose of microorganism (as reduced to viable cells) is preferably from 105 cells to 1010 preferably from 108 cells to 1010 cells, in particular cells” (see bottom of page 9)
It is clear that Barberán discloses Gordonibacter sp. which is able to metabolize ellagic acid and ellagitannins into urolithins. Barberán discloses that pomegranate punicalagina elagitannins can be used or ellagic acid of nut strawberries, raspberries, medicinal plants as well as tissues rich in elagitnannins (oak leaf, acorns etc.). The composition is intended for persons who have medium-to-low or no urolithins producer status and to treat diseases associated from such low or no production. Therefore, Barberán discloses the same method for changing a phytonutrient status of a subject (medium-to-low or now urolithins to more than medium or low urolithins) which comprises of assessing a level of a preselected phytonutrient or a preselected phytonutrient precursor compound within the subject because one must identiyfy and determine their status, and subsequently administering a phytonutrient precursor compound (ellagic acid and ellagitannins), and probiotic which would be adapted to mediate a preselected phytonutrient precursor compound in the gastrointestinal tract of the subject, thereby changing the phytonutrient-producer status of the subject.
Regarding claims 3-4, 13, Barberán discloses “there is also no known method capable of isolating and detecting or quantifying urolithin producing microorganisms in stool samples or in any other type of biological sample” (see page 6, last para.).
Regarding claim 5, Barberán discloses, “the use of said microorganisms for the development of procedures for the production of urolithins constitutes another aspect of the present invention. These procedures consist of the transformation of elagitannins, ellagic acid and derivatives, which are phenolic compounds present in the diet that cannot be absorbed, in different absorbable urolithins in the intestine (urolithin A, B, C, D, E, M6, M5, M7 and related metabolites) using either the microorganism object of the present invention (Gordonibacter sp. CEBAS 1 / 15P) or G. pamelaeae DSM 19378 T. The process of production of urolithins object of the present invention, in comparison with the production of urolithins by organic synthesis, leads to products with a greater chemical diversity (eg. pentahydroxy urolithin, tetrahydroxy urolithin and urolithin C) and with less chemical residues per Therefore, with greater safety and safety for the consumer” (see page 3, 2nd para.).
“In a more specific procedure, the new microorganism of the present invention (Gordonibacter sp. CEBAS 1 / 15P) that has an ability to produce urolithins can be selected by screening. Specifically, a sample (eg, feces) that possibly contains urolithin-producing microorganisms is seeded in a solid growth medium (eg DRCM Oxoid), incubated in anaerobiosis at 37 ° C and after 72 h, the isolated colonies are sub -cultivate in a liquid growth medium (eg brain heart broth) with ellagic and the transformation of ellagic acid into urolithins is monitored. Examples of samples that may contain urolithin-producing microorganisms are feces and contents of the digestive tract (descending colon, blind ...) of a human or animal subject producing urolithins. The stool sample used is preferably homogenized in a diluent using a filter bag and a shovel homogenizer. One of the bacteria that have the ability to produce urolithins and that belongs to the genus Gordonibacter has been obtained by the procedure previously mentioned” (see page 9, first para.).
Claim Rejections - 35 USC § 103
Claims 1-7, 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over Francisco TOMÁS BARBERÁN et. al. (WO2014147280A1) and Saeid Bathaei (BE1020284A3).
Barberán discloses Microorganisms capable of producing urolithins characterized because: (i) They are selected from biological samples of urolithin-producing individuals, (ii) They are capable of growing in an appropriate culture medium containing ellagic acid and / or elagitannins, (iii) They are capable of producing urolithins when they are incubated in culture medium (ii), for a given and sufficient period of time, under appropriate atmosphere and temperature conditions, (iv) The produced urolithins can be determined by suitable techniques, and because they belong to bacterial species of the Gordonibacter genus selected from Gordonibacter sp. CEBAS 1 / 15P (DSM 26536) or Gordonibacter amelaeae (DSM 19378) (see claim 1).
Barberán discloses “Urolithins are compounds that can be absorbed in the intestine and have biological activity in humans and other mammals (estrogen modulator, anti-inflammatory and anticancer activity, prebiotic effects, cardiovascular prevention, etc.). Urolithins are produced by the gut microbiota from elagitannins and ellagic acid from the diet (Cerdá et al., Agrie. Food Chem., 2005, 53, 5571-5576) that cannot be absorbed unlike urolithins. Among the individuals there is a great variability in urolithin production, being some high, medium, low or null individuals producing these compounds (Cerdá et al., Agrie. Food Chem. 2005, 53, 227-235). Various urolithins (A, B, C, D, M6, M5, M7, isourolithin A) have been described, which differ from each other by the number of hydroxyl groups and their position. Several urolithins (A, B, C and conjugates thereof with glucuronic acid and sulfate) have been identified in biological fluids (urine and blood) and in human and animal organs (rumen of cows, human prostate, mouse prostate, cardiac tissue ...) (Cerdá et al., Eur. J. Nutrition., 2003, 42, 18-28; González-Sarrias et al., Mol. Nut. Food Res., 2010, 54, 31 1 - 322; J. Agrie. Food Chem., 2009, 57, 5623-5632; J. Agrie. Food Chem., 2012. 60, 3068-3077.). This shows that urolithins are absorbed in the intestine by passing into the bloodstream and the various organs exerting a biological effect. Consequently, both the identification and isolation of microorganisms capable of producing urolithins and their use as probiotics, as well as the procedures capable of producing these compounds are of great interest, so there have been different technologies aimed at addressing these issues”.
“Therefore, a specific aspect of the present invention consists of species of the genus Gordonibacter capable of growing in growth media, liquids and solids and in the presence of phenolic compounds in the diet” (see page 6).
Barberán discloses “the food / beverage compositions, dietary supplements, pharmaceutical or probiotic compositions of the present invention that contain a microorganism that has a urolithin production capacity can be employed as a urolithin level enhancer in the organism, blood, intestine (for example, the large intestine), etc., for the purpose of treating, improving, preventing, etc. a variety of diseases and disorders such as arteriosclerosis and other cardiovascular diseases, breast cancer, prostate cancer, inflammatory bowel diseases and premenstrual syndrome. In particular, if food / beverage compositions, dietary supplements, pharmaceutical or probiotic compositions are applied to a human individual who has no urolithin production capacity (non-producer) or a human individual who has a low capacity for urolithin production, A variety of diseases and disorders where urolithins are effective can be prevented in everyday life. In addition, the composition is preferably applied to middle-aged or elderly human subjects, who have a higher risk of suffering from the chronic diseases mentioned” (see page 9, para. 3). This teaching with the broadest reasonable interpretation implies assessing a level of preselected phytonutrient or a preselected phytonutrient precursor compound within the subject as it describes having to identify a human or individual with low or no urolithin production capacity and one would have to asses the levels of the phytonutrient (urolithin) in order to know their status.
Barberán discloses “metabolites produced by Gordonibacter sp. 1: pentahydroxy-urolithin (pentahydroxy-urolithin or urolithin M5), 2: Ellagic acid (ellagic acid). 3: tetrahydroxy-urolithin (tetrahydroxy urolithin or urolithin M6), 4: urolithin C (urolithin C)” (see page 8, figure 1).
Barberán discloses “taking into account that from certain dietary elagitannins ellagic acid is released in the gastrointestinal tract, compounds such as pomegranate punicalagina, elagitannins can be used instead of ellagic acid of nuts, strawberries, raspberries, medicinal plants, as well as plant tissues rich in elagitannins (oak leaf, acorns etc). Alternatively, intermediate metabolites of conversion of ellagic acid to urolithin A can also be used, for example, urolithin M5, urolithin D, etc. This synergistic combination (elagitannins and / or ellagic acid and / or sources thereof, together with the microorganism) provides a more potent urolithin level enhancer. The elagitannins and / or ellagic acid used in the present invention can be either a commercial product or a synthetic product or a natural extract. Alternatively, a natural product containing a large amount of elagitannins or one of its processed products can also be used. Specific examples of products that contain a large amount of elagitannins include pomegranate, nuts, strawberries, chestnuts, blackberries, raspberries, etc.” (see last para. page 9).
Barberán discloses “Preferably, the dose is predetermined to achieve the desired effect according to different modes of use, for example, the target individual and the target diseases and disorders. The daily dose of microorganism (as reduced to viable cells) is preferably from 105 cells to 1010 preferably from 108 cells to 1010 cells, in particular cells” (see bottom of page 9)
It is clear that Barberán discloses Gordonibacter sp. which is able to metabolize ellagic acid and ellagitannins into urolithins. Barberán discloses that pomegranate punicalagina elagitannins can be used or ellagic acid of nut strawberries, raspberries, medicinal plants as well as tissues rich in elagitnannins (oak leaf, acorns etc.). The composition is intended for persons who have medium-to-low or no urolithins producer status and to treat diseases associated from such low or no production. Therefore, Barberán discloses the same method for changing a phytonutrient status of a subject (medium-to-low or now urolithins to more than medium or low urolithins) which comprises of assessing a level of a preselected phytonutrient or a preselected phytonutrient precursor compound within the subject and administering a phytonutrient precursor compound (ellagic acid and ellagitannins), and probiotic which would be adapted to mediate a preselected phytonutrient precursor compound in the gastrointestinal tract of the subject, thereby changing the phytonutrient-producer status of the subject.
Regarding claims 3-4, Barberán discloses “there is also no known method capable of isolating and detecting or quantifying urolithin producing microorganisms in stool samples or in any other type of biological sample” (see page 6, last para.).
“In a more specific procedure, the new microorganism of the present invention (Gordonibacter sp. CEBAS 1 / 15P) that has an ability to produce urolithins can be selected by screening. Specifically, a sample (eg, feces) that possibly contains urolithin-producing microorganisms is seeded in a solid growth medium (eg DRCM Oxoid), incubated in anaerobiosis at 37 ° C and after 72 h, the isolated colonies are sub -cultivate in a liquid growth medium (eg brain heart broth) with ellagic and the transformation of ellagic acid into urolithins is monitored. Examples of samples that may contain urolithin-producing microorganisms are feces and contents of the digestive tract (descending colon, blind ...) of a human or animal subject producing urolithins. The stool sample used is preferably homogenized in a diluent using a filter bag and a shovel homogenizer. One of the bacteria that have the ability to produce urolithins and that belongs to the genus Gordonibacter has been obtained by the procedure previously mentioned” (see page 9, first para.).
Regarding claim 5, Barberán discloses, “the use of said microorganisms for the development of procedures for the production of urolithins constitutes another aspect of the present invention. These procedures consist of the transformation of elagitannins, ellagic acid and derivatives, which are phenolic compounds present in the diet that cannot be absorbed, in different absorbable urolithins in the intestine (urolithin A, B, C, D, E, M6, M5, M7 and related metabolites) using either the microorganism object of the present invention (Gordonibacter sp. CEBAS 1 / 15P) or G. pamelaeae DSM 19378 T. The process of production of urolithins object of the present invention, in comparison with the production of urolithins by organic synthesis, leads to products with a greater chemical diversity (eg. pentahydroxy urolithin, tetrahydroxy urolithin and urolithin C) and with less chemical residues per Therefore, with greater safety and safety for the consumer” (see page 3, 2nd para.).
Barberán does not specifically teach the composition to further comprise fiber or starch.
Bathaei teaches “a composition for obtaining positive health effects based on the active role of certain dietary fiber as functional food ingredients in combination with a mixture of enzymes that optimize the functioning of the intestinal flora and in addition with a mixture of dietary supplements to restore colonocytes, in which the dietary fibers comprise a mixture consisting of Xylo-oligosaccharides (XOS) and / or xylane, fructo-oligosaccharides (FOS) and Gluco-oligosaccharides (GOS) and wherein at least one of the enzymes can break up (digest) at least one type of these dietary fibers” (see claim 1).
Bathaei teaches of patents that describes prebiotic compositions containing soluble fibers, in particular Fructo-oligosaccharides (FOS) and galacto-oligosaccharides and their use in the treatment of prevention of gastrointestinal tract imbalances, such as diarrhea, constipation and inflammatory bowel disease (IBD). Galacto-oligosaccharides are also known carbohydrates.
Bathaei also teaches wherein the US patent document (US20080261919A1) describes synergistic compositions with components selected from a broad group including modified or unaltered starch or partially hydrolyzed versions thereof, fructo-oligosaccarides, trans-galacto-oligosaccarides, xylo-oligosaccarides (XOS), beta-glycan and partially hydrolysed versions and, if desired, other plant extracts, mineral components, vitamins, and additives (see page 6, para. 6).
Therefore it would have been obvious to persons having ordinary skill in the art to also add fibers and carbohydrates in the composition taught by Barberán because they are known for benefiting the gut microbiome and prevention and treatment of IBD and gastrointestinal imbalances. It would have also been obvious to measure the phytonutrient production in comparison to population data as this is commonly done to find epidemiological, genetic, community, and other evidence to support population studies. Comparing levels to other individuals would help to gather data in support of population statistics and could help guide practitioners of where current normal levels are at.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Francisco TOMÁS BARBERÁN et. al. (WO2014147280A1) and Saeid Bathaei (BE1020284A3) as applied to claims 1-7, 9-21 above, and further in view of Pilar Gaya et. al. (Bifidobacterium pseudocatenulatum INIA P815: The first bacterium able to produce urolithins A and B from ellagic acid, Journal of Functional Foods 45, March 2018; 95-99).
Barberán teaches the instant invention however is silent on the bacterial probiotic species being either Bifidobacterium or Lactobacillus.
Gaya teaches “Urolithins are microbial metabolites derived from ellagic acid by the action of intestinal bacterial. Potential beneficial effects of urolithins A and B on certain types of cancer and on muscular health during aging have been demonstrated. In this work, urolithin production by 48 strains of bifidobacteria and 1070 bacterial isolates from the faeces of a healthy woman whose intestinal microbiota produced uroltihins A and B was screened. Bifidobacterium pseudocatenulatum INIA P815 was the only strain able to produce urolithins A and B from ellagic acid. Influence of different media on the strain metabolism showed that the production of urolithins could be regulated. The identification of a bifidobacterial strain producing urolithins A and B opens the possibility for its application as probiotic in functional foods and in the development of nutraceuticals” (see abstract).
Therefore it would have been obvious to persons having ordinary skill in the art to use the Bifidobacterium pseudocatenulatum INIA P815 which is known to produce both urolithins A and B, because Barberán teaches of other bacterial species known to produce the same phytonutrient and selecting the species taught by Gaya would have been prima facie obvious as both species can be selected for the method to produce the compounds.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8-13, 21-22, 24-27 of U.S. Patent No. US11730778. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to the same method steps and the only difference of the instant claims is the composition which is administered optionally can comprise a prebiotic. The claims comprise overlapping method steps with same end effects.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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