Prosecution Insights
Last updated: April 18, 2026
Application No. 18/363,325

USE OF MALTODEXTRIN AS AN EXCIPIENT

Non-Final OA §103§112
Filed
Aug 01, 2023
Examiner
MOEHLMAN, ANDREW TERRY
Art Unit
1655
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dupont Biosciences Aps
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant
99%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
56 granted / 82 resolved
+8.3% vs TC avg
Strong +64% interview lift
Without
With
+63.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
32 currently pending
Career history
114
Total Applications
across all art units

Statute-Specific Performance

§101
5.9%
-34.1% vs TC avg
§103
33.9%
-6.1% vs TC avg
§102
14.4%
-25.6% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 82 resolved cases

Office Action

§103 §112
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. Priority The instant application i s a continuation of US Patent App. No. 16/328,175 (filed February 25, 2019, now abandoned), which claims priority under 35 USC § 371 as a national phase of Int . Ap p . No. PCT/EP2017/047521 (filed August 18, 2017; published March 1, 2018 as Int'l Publ. No. W02018/039056), which, in turn, claims priority to Europe Patent Application No. 16185880.8 (filed August 26, 2016). Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) , 120, 121, 365(c), or 386(c) . It is noted, however, that applicant has not filed a certified copy of the EP a pplication 16185880.8 as required by 37 CFR 1.55. The effective filing date for claims 7-8, 11, 13-16, 19-31 is August 18, 2017. Response to Amendment Applicant’s amendment to the claims filed 3/18/2024 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims. Claims 7-8, 11, 13-16, 19-31 are pending and are examined on the merits herein. Drawings The drawings are objected to because : 1. T he title caption for FIG. 3 and FIG. 4 both recite “Bifidobacterium lactis (Strain BBL) stability”. It appears that this is incorrect in FIG. 4, which should instead say “ Bifidobacterium lactis (Strain BB I ) stability ” as stated on Page 5, line 25 of the specification. Also, the subtitles within the box in the graph state “Aw impact on the Bifidobacterium lactis (Strain BB l ) stability” in FIG. 3 and “Aw impact on the Bifidobacterium lactis (Strain BB i ) stability” in FIG. 4. For clarity, the subtitle s in both FIG. 3 and FIG. 4 (i.e. the title within the box in the graphs) should either be removed or the lowercase letters of strain names should be corrected to “( Strain BB L)” and “( Strain BB I)”, respectively. 2. The trademarked terms BENEFIBER, PREJEL, and MALTRIN a ppear in FIG.1 without any indication that these are trademarked products, nor an adequate description of the generic product in the figure description portion of the specification . Similarly, the trademarked term NCFM ® is used in both FIG. 2 and FIG. 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The disclosure is objected to because of the following informalities: TRADE NAMES, TRADEMARKS, AND OTHER MARKS USED IN COMMERCE: The use of the terms NCFM® (see pages 5, 10, 12 and FIGs. 2 and 5, NCFM® is a trademarked strain owned by The North Carolina Agricultural Foundation, Inc ); AQUALAB (pg. 9); DECAGON (pg. 9); PROCELL (pg. 9); MUNTERS (pg. 9); BENEFIBER, PREJEL, MALTRIN, SOLANI AMYLUM (all in Table 1, Table 2, Table 3 and used throughout the specification ); which are each a trade name or a mark used in commerce, has been noted in this application. The trademarked terms NCFM , BENEFIBER, PREJEL, and MALTRIN also appear in the drawings, as indicated above. The term s should be accompanied by the generic terminology; furthermore the term s should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term s. Applicant’s assistance in identifying other trademarks is requested. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks (see MPEP 608.01(v) and 608.01(u)). Appropriate correction is required. Claim Objections Claims 8 and 23 are objected to because of the following informalities: In claims 8 and 23, the phrase “ Sodium hydroxide (NaOH), Potassium hydroxide (KOH) or Ammonium hydroxide (NH 4 O H) ” should instead be “s odium hydroxide (NaOH), p otassium hydroxide (KOH) or a mmonium hydroxide (NH 4 O H) ”. Chemical names are not capitalized. Claims 28-31 use the lowercase terms. Claims 7 and 8 are objected because 37 CFR 1.57 (c) states o ne or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. Claim 11 is numerically after claims 7 and 8. Suggest making new claims 32 and 33 that depend from claim 11 and cancelling claims 7 and 8. Appropriate correction is required. Claim Interpretation Terms and limitations in the claims are given their Broadest Reasonable Interpretation (B.R.I.) in light of the specification. The specification defines “ dextrose equivalent (DE) ” as a measure of the amount of reducing sugars present in a sugar product, relative to dextrose (glucose), expressed as a percentage on a dry basis (see page 2). The phrase “ water activity (AW) ” is defined in the specification as the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure of water . Claim Rejections - 35 USC § 112(a)- Enablement 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 7-8, 11, 13-16, and 19-31 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 enablement requirement . The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. MPEP § 2164 sets forth that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt , 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The factors considered to be most relevant to the instant invention are addressed in detail below. (A) The breadth of the claims and (B) nature of the invention: With respect to breadth of the claim s , the standard under 35 U.S.C. §112(a) entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the methods of claims 11 and 15 is that they improve the shelf-life of any species and strain of probiotic bacteria. Further, the claims allow for any proportion of maltodextrin to the bacteria components and for the potential addition of a number of additional components. From the specification, it can be gleaned that the nature of the Applicant’s invention is one of optimization of particular components in a freeze-dried powder composition including potato maltodextrin having a dextrose equivalent (DE) of 20 with one of Lactobacillus acidophilus strain NCFM , Bifidobacterium lactis strain BBL, and B. lactis strain BB I, when the compositions have a water activity (Aw) below 0.1. (C) The state of the prior art , (D) t he relative skill of those in the art , and (E) the predictability or unpredictability of the art: Shimoni et al. (US PGPub No. 20100189767), discloses compositions comprising probiotic microorganisms encapsulated with a matrix comprising a combination of one or more disaccharide or oligosaccharide sugars, e.g. trehalose, and one or more dextrins , including maltodextrin ([0009], claims 52 and 54). Shimoni demonstrates that such probiotic compositions have improved viability and are more stable during production and during prolonged storage ([0008]-[0010], and FIG. 2, see [0022]). Shimoni teaches preferred probiotic organisms (i.e. organisms with a potential health benefit to a subject) to provide include, inter alia , the microorganisms Bifidobacterium animalis subsp. lactis , e.g. Bifidobacterium lactis , and Lactobacillus acidophilus ([0034]-[0035]) , as recited in the instant claims. Shimoni also suggests the use of Bifidobacterium infantis , Lactobacillus plantarum, Bifidobacterium animalis , Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus casei., Lactobacillus rhamnosus , and Lactobacillus GG ([0035]). In working examples, Shimoni uses a combination of probiotic microorganisms comprising Lactobacillus paracasei , Lactobacillus acidophilus, and Bifidobacteria bifidum and demonstrates viability after prolonged storage with a maltodextrin DE19 (FIGs 2B) and maltodextrin DE19 with an equal amount of trehalose (FIG 2D). Shimoni demonstrates a large amount of experimentation and optimization including testing different maltodextrins (with different DE amounts), with or without additional trehalose, and with varying spray drying/freeze-drying conditions (see Table 2, and Table 4, Example 4). From this data, one can ascertain that bacterial v iability is affected by the amount of maltodextrin present ( Table 4, rows 4, 5, and 6 which differ only in the solid concentration used) and the presence of other ingredients such as trehalose (compare rows 3 and 8 in Table 4 , which differ only in using maltodextrin alone versus a maltodextrin-trehalose mixture). Elsewhere in Shimoni , see Example 3 and Table 3 on pg. 17-18 , the data suggests that water activity is not necessarily correlated with increased probiotic viability. Among these tested samples using maltodextrin DE=19, the sample with the highest viability (row 5) had a water activity of 0.245 and all samples with Aw less than 0.1 as claimed had worse bacterial viability than samples with Aw above 0.2 (in Table 3) . Thus, although these were not freeze-dried samples (used a vacuum spray drying technique) there was no apparent benefit for having a Aw less than 0.1 with these particular combination of bacteria. Cevallos et al. (US PGPub No. 20140093613) pertains to the stabilization of biological material for ingestion by an individual , and teaches a stabilization mixture comprising hydrolyzed protein, which provides improved stability to a probiotic organism when the probiotic is included in a nutritional composition (Abstract). Regarding the problem of moisture in probiotic stability, Cevallos states that “ In addition, the inherent moisture of the product poses a challenge in that probiotics generally are sensitive to water, especially in combination with high temperature. There is a need to deliver sufficient protection to probiotics under intermediate moisture conditions (i.e. water activity of about 0.2 and higher, and up to about 0.4 or higher) and high temperatures during distribution and storage (i.e. temperatures of at least about 30 ° C, and up to and above 40°C) when incorporated into nutritional agents. ” ([0006]) To address this problem and to improve bacterial stability, Cevallos teaches using: ( i ) a hydrolyzed protein, (ii) a first carbohydrate selected from the group consisting of sucrose, maltose, lactose, trehalose, maltotriose , maltodextrin having a dextrose equivalent ("DE") of about 2 to about 6, and any combination thereof, and (iii) a second carbohydrate selected from the group consisting of inulin, polydextrose, galactooligosaccharides , fructooligosaccharide , starch, maltodextrin having a dextrose equivalent of greater than about 8 ([0009]-[0012]). The only bacterial strain taught in Cevallos is Lactobacillus rhamnosus GG (LGG) , demonstrated in a protective matrix according to the invention therein (see FIGs 1-3; [0023]). Tables 1-4 of Cevallos demonstrates exemplary embodiments of the protective composition, which includes multiple components, including maltodextrin > 8 DE. It is apparent from the teachings in Cevallos that even these samples having a relative high available water (Aw) content of 0.28 are viable across multiple weeks at 30°C ([0086]; FIG. 1). From the teachings and data present in Cevallos , one can conclude that the effects of moisture on bacterial stabilization are unpredictable, and are greatly affected by specific components in the formulation, and this reference teaches optimization for just one bacterial species ( Lactobacillus rhamnosus GG ). Vesterlund et al. ( 2012. “ Water activity in dry foods containing live probiotic bacteria should be carefully considered: A case study with Lactobacillus rhamnosus GG in flaxseed. ” International Journal of Food Microbiology , 157 (2), pp.319-321 ) demonstrates that shelf-life of a probiotic-maltodextrin mixture is associated with water activity ( see Fig . 1 on pg. 320, filled triangles). T he lowest water activity tested (0.11 , top panel ) was highly stable despite having a slightly higher water activity than that which is so claimed, with only a “very low” reduction of 0.58 log 10 units over 14 months (pg. 320 , right col. , 1 st ¶ ). Vesterlund also teaches that “ However, incorporating pr o biotics into new food matrices, and keeping them alive during their shelf life, is a significant challenge - viability can be lost during the manufacturing process, transportation or during storage of the probiotic product. Various environmental factors such as temperature, oxygen, humidity (also in the case of high water activity products), pH and presence of other cultures (starter or non-starter) can also lower the viability of probiotics ” (pg. 319, left col, 1 st ¶ ). Vesterlund concludes by stating that “ When developing new probiotic food products, a necessary step in development is to ensure that the probiotic is able to survive well in the food product, considering the food matrix, processing conditions and storage conditions. It is also important to ensure that the production method for the probiotic is appropriate for preserving its original properties ” (pg. 321, left col, 2 nd ¶ ). Sohail et al. ( 2012. “ The viability of Lactobacillus rhamnosus GG and Lactobacillus acidophilus NCFM following double encapsulation in alginate and maltodextrin. ” Food and Bioprocess Technology , 6 (10), pp.2763-2769 ) pertains to the methods for encapsulating and preserving Lactobacillus rhamnosus GG (LGG) and Lactobacillus acidophilus NCFM (LNCFM) in alginate microgel particles (microbeads) by a novel dual aerosols method , and teaches that these probiotics in a microbead gel matrix were further stabilized in maltodextrin solids by either spray or freeze-drying to form probiotic microcapsule powders (Abstract). Sohail teaches that “ spray drying results in improved subsequent probiotic survivability compared to freeze drying and that alginate gel encapsulation can improve the survivability following freeze-drying in a probiotic dependent manner (Abstract, last ¶, on pg. 2763). Sohail states that “ probiotics are highly sensitive to environmental factors (heat, oxygen, and humidity) during storage and drying which can cause cell wall deterioration, lipid oxidation, or changes in the cell membrane ” (the ¶ spanning pgs. 2763-2764). Sohail teaches applying a maltodextrin with a DE lower that which is instantly claimed ( Maltodextrin , Fieldose 10C DE 9.8 , see pg. 2764 under “ Materials ”). Regarding the water activity parameter, Sohail teaches that w ater activity for all the powders were between 0.16 and 0.23 , and states that “ It is generally accepted that water activity should be below 0.25 and the moisture content below 5 % in order to ensure stability of dried preparations of bacterial cells ” (pg. 2766, right col, 1 st ¶ ). Sohail teaches that results showed insignificant difference in the survivability of bacteria during storage at 4 °C with water activity levels of 0.11 and 0.23 ( pg. 2766, right col, 1 st ¶ ). Sohail found that that spray-dried LNCFM is significantly (P< 0.05) more stable that freeze-dried LNCFM during storage at 4°C (pg. 2766, right col, last ¶ and Fig. 4). Sohail states that “ Double-encapsulated LGG (alginate gel + maltodextrin) produced by freeze-drying contained 5.07 log CFU/g (3.32 log CFU/g reduction) after 6 months. ” (pg. 2767, right col, last ¶ and Fig. 6). Sohail concludes that t he improved stability of freeze-dried LGG powders is in contrast to LNCFM bacteria which displayed better storage stability following spray drying and that for LNCFM, freeze-dried free and encapsulated bacteria showed similar survivability (Figs. 3 and 4) providing further evidence that tolerance to drying-induced stress depends upon the species and possibly type of bacterial strain (pg. 2768 ). Rokka and Rantamäki ( 2010. “ Protecting probiotic bacteria by microencapsulation: challenges for industrial applications. ” European Food Research and Technology , 231 (1), pp.1- 12 , hereafter called “ Rokka ”) is a review article that discusses m icroencapsulation technology which can be used to maintain the viability of probiotic bacteria during food product processing and storage (Title, Abstract). Rokka concludes that “ Future challenges in the field include recognition of new potent applications, selection of appropriate techniques, materials and bacterial strains ...” (Abstract). Rokka demonstrates a large number of Bifidobacterium and Lactobacillus strains applied in encapsulation studies (see Table 2, on pg. 3). Rokka demonstrates there is a wide variety of encapsulating compositions known the art, and teaches one which incorporates 30% maltodextrin with spray-drying (see Table 5). Regarding freeze-drying, Rokka teaches that the drying media can have a greater effect on the stability of probiotics than microencapsulation itself and that “ Wheat dextrin and poly - dextrose have proven promising fibre carriers to protect Lactobacillus rhamnosus during freeze drying ” (pg. 7, right col). Regarding the suitability of different probiotic products, Rokka teaches that the survival of probiotic bacteria during processing, storage, and in gastric conditions is highly dependent on the strain used , and stress es that the s tability of the strain is one of the main criteria in selecting suitable probiotics (pg. 6, right col, ¶ under “ Survival of microencapsulated probiotics ”) . Regarding survivability assays, Rokka teaches “ Survival rates of probiotic bacteria after various treatments have generally been studied by the plate count method, which is easy to carry out. Cultivability on plate, however, does not always tell the whole truth about the viability of bacteria. A non-cultivable population might still be metabolically active and provide the desired health-promoting e ff ect in its target ” and describes the use of live/dead assays and flow cytometry to learn more about the metabolic status of revived bacteria (pg. 6, right col, last 2 ¶ s). Thus, as evidenced by the relevant art around the time of the invention, means for predicting if any and all bacteria l strains are suitable in the claimed freeze-drying and storage method is highly unpredictable. The relative skill of those in the art is high , and many techniques for drying and encapsulating probiotic bacteria are known, as evidenced by the cited art. Further, assays for determining water activity and survivability are well-known to the art. However, from the referenced art above, it is evident that one of skill in the art would be aware of the high amount of variability among different species and even different strains of bacteria, and thus, would turn to the instant specification for further guidance on the selection of bacterial strains for use with the claimed method and compositions of the formulations . (F) The amount of direction or guidance presented and (G) the existence of working examples: The specification teaches that probiotics are commonly administered in combination with various excipients and “the choice of the excipients is then critical to provide a probiotic powder with an optimal transparency, dispersibility, and shelf-life stability” (pg. 1 , lines 19-20 of the specification dated 8/1/2023 ). The specification also teaches how to prepare probiotic formulations ( only those having 30 percent probiotics) by dry blending bacteria and maltodextrin (pg. 10 , last paragraph ending on pg. 11). The specification further teaches that only “ MD 20 ” samples were used for assays on the shelf-life of probiotic blend s (pg. 10 , l ine 18 , FIGs 2-4 ) and does not explicitly disclose the Aw of the maltodextrin at the time of blending. The specification describes maltodextrins with water activities both above and below 0.1 that could be used to generate the composition (Table 6 on pg. 10). It is noted that the specification states that “CFU [colony forming units] and Aw [water activity] were measured at time 0, 1, 3 months to evaluate the impact of excipient Aw and pH on stability performance” (pg. 11 , lines 5-6), but it appears that only 1 month data was provided. The disclosure describes just two probiotic compositions comprising Lactobacillus acidophilus strain NCFM, maltodextrin with a DE20 , and having a Aw less than 0.1 ( see the left most samples in FIG. 2). With L. acidophilus strain NCFM , the bacterial recovery after the 14 day test was increased relative to formulations with a higher Aw, but the composition’s Aw had only minimal effect on the recovery after storage for 1 month at 30°C. P robiotic formulations with the probiotic bacteria Bifidobacterium lactis strains BBI and BBL ( FIGs. 3-4) were also tested ; however, none of those probiotic formulations demonstrated had a Aw below 0.1 and therefore do not fall within the bounds of the claim. Further, evidence and examples in the specification indicate that optimization of the pH is important for improving survival of these bacterial strains (see Fig. 5), and discusses the addition of suitable bases in order to achieve improved pH. However, the range of pH is not limited in either the independent claims or the dependent claims that recite adding a base. Dependent claims 7-8, 22-23, and 28-31 require a base is added, but the concentration and amounts are not limited and there is no practical limit to the desired pH. It is evident from the specification, on page 12, that pH 6.9 is optimal for the B. lactis strain BBL and pH 7.25 is optimal for B. lactis strain BBI. Thus, the specification demonstrates that even strains of the same species can have different results when it comes to optimizing the conditions for prolonged storage stability. The data provided in the specification regarding Lactobacillus acidophilus strain NCFM and Bifidobacterium lactis strains BBI and BBL is evidence that different species of bacteria will perform differently in similar storage conditions, and even different strains of the same species can have diverging effects regarding storage stability. The specification as filed does not provide guidance that overcomes the described unpredictability within the art. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification. (H) The quantity of experimentation necessary: T he standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea ( see MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the full breadth of the claimed method without first making a substantial inventive contribution. Given that the nature of the invention is improving the shelf-life of a probiotic, a person of ordinary skill in the art would have had to perform multiple trials for each strain desired to be used, to optimize the freeze-drying conditions, formulation, coating, and storage conditions in order to demonstrate whether invention could be used with a reasonable expectation of success for any possible strain of bacteria commensurate with the claims scope. Considering the state of the art , especially as discussed by Shimoni and further reviewed in Rokka , and given the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to perform the claimed method with a reasonable expectation of successfully for improving the shelf-life of a ny probiotic bacteria l strain and/ or any probiotic formulation . It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation. Therefore, claims 11 and 15 are rejected because the disclosure fails to meet the enablement requirement . The dependent claims 7-8, 11, 13-16, and 19-31 are also rejected under 35 U.S.C. § 112(a), because these claims, dependent on either claim 11 or 15 , fail to obviate the rejection. Although dependent claims 13-14, 20-21, and 28-31 limit the bacteria species to one of Lactobacillus acidophilus and Bifidobacterium lactis , only specific strains of these were reduced to practice in the disclosure and there existed variation in the results between the two different strains of Bifidobacterium lactis . Thus, it is unclear if the survival benefits can be afforded to all strains of these bacteria, according to the full breadth of the claimed inventions. Claim Rejections - 35 USC § 112(a)- Written Description 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 7-8, 11, 15, 16, 19, and 22-27 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 claims 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. MPEP 2163 .03(V) states that an original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) ( en banc). In the instant case, c laim s 11 and 15 recites a method for improving the shelf life of freeze-dried probiotic bacteria or formulations thereof . The claim s are broadly drawn to any species of probiotic bacteria that is mixed with maltodextrins in any proportion, and that may be formulated with any other components (as these are all comprising claims). The dependent claims 7-8, 16, 19, and 22-27 fail to practically limit the encompassed genus of probiotic bacteria. According to the B.R.I. of the claim, when viewed in light of the specification, there exists a nearly limitless number of probiotic bacteria and combinations thereof with maltodextrin according to the claimed scope. Comparatively, the specification only recites a small number of species of the broad genus that meets the recited limitations. MPEP § 2163.(II)(A)(3)(a) states that 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 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 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. The specification fails to reasonably describe the full genus of the claimed invention by providing identifying characteristics or functional properties of the bacteria and compositions thereof so that one can predict or conclude that the Applicants were in possession of more species than those reduced to practice herein. The instant specification does not disclose relevant identifying characteristics, such as key physical properties or functional characteristics of bacteria such that the entirety of the claimed genus is encompassed by the description in the disclosure. The specification states, generally, that probiotic bacteria are known to the art, and describes probiotic bacteria in general terms and with functional characteristics such as survival in digestive tract, beneficial health effects, and lack of pathogenicity (see pg. 3, lines 27-38). With regard to the species of the provided probiotic bacteria , the specification reduces to practice only a few probiotic compositions comprising Lactobacillus acidophilus and maltodextrin with a dextrose equivalent (DE) around 20 and water activity less than 0.1 ( see FIG. 2) . The specification also reduces to practice the invention using two different strains of Bifidobacterium lactis (BBL and BBI), which have different results in viability when the Aw is modified (see FIGs. 3 and 4, and pg. 12, section 2.2). Thus, the specification only provides only 2 working example of the claimed genus of any probiotic bacteria , which cannot be considered a sufficient description of a representative number of species by actual reduction to practice of the full breadth of the vast genus. There is no evidence that, at the time of filing, the Applicant possessed additional representative species of the full genus recited in the claims beyond those provided in the working examples. From the art, the review article Rokka (2010. “Protecting probiotic bacteria by microencapsulation: challenges for industrial applications.” European Food Research and Technology , 231 (1), pp.1-12, see above ) discusses microencapsulation technology which can be used to maintain the viability of probiotic bacteria during food product processing and storage (Title, Abstract). Rokka concludes that “Future challenges in the field include recognition of new potent applications, selection of appropriate techniques, materials and bacterial strains...” (Abstract). Rokka demonstrates a large number of Bifidobacterium and Lactobacillus strains applied in encapsulation studies (see Table 2, on pg. 3). Rokka demonstrates there is a wide variety of encapsulating compositions known the art, and teaches one which incorporates 30% maltodextrin with spray-drying (see Table 5). However, r egarding the suitability of different probiotic products, Rokka teaches that the survival of probiotic bacteria during processing, storage, and in gastric conditions is highly dependent on the strain used, and stress es that the stability of the strain is one of the main criteria in selecting suitable probiotics (pg. 6, right col, ¶ under “Survival of microencapsulated probiotics”) . Therefore, in light of the guidance and examples in the specification , taking into account the general knowledge in the art , one having ordinary skill in the art around the time of filing would have concluded that the specification demonstrated possession of a method for improving the shelf life of freeze-dried probiotic bacteria or formulations thereof comprising Lactobacillus acidophilus and Bifidobacterium lactis, but one would not have concluded that these two species comprise a “representative number of species” within the claimed genus of any probiotic. For these reasons, the disclosure fails to provide adequate written description to support the entirety of the broad genus claim to any and all probiotic bacteria. Claims 11 and 15 are thus rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification in such a way as to reasonably convey to a skilled artisan that the inventor, or a joint inventor, had possession of the claimed invention. The dependent claims 7-8, 16, 19, and 22-27 are also rejected under 35 U.S.C. § 112(a), because these claims , dependent on either claim 11 or 15, do not exclude the full breadth of the independent claims regarding the species of bacteria and thus fail to obviate the rejection . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 11, 13-15, 20-21, and 24-27 FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" are rejected under 35 U.S.C. 103 as being unpatentable over Shimoni et al. (US PGPub No. 20100189767). Shimoni pertains to compositions of bioactive agents comprising probiotic microorganisms as well as methods for preparing these compositions (Abstract, Title). The methods comprise microencapsulating live microorganisms to produce a dry formulation and optionally coating the microcapsules while retaining to a significant extent the viability of the microorganisms ([0001]). Shimoni teaches that p robiotics are challengingly to provide in dry forms, encapsulated or otherwise prepared, wherein viability is significantly preserved, due to their sensitivity to processing and storage conditions and teaches an unmet need for dry forms and probiotic compositions capable of maintaining high viability and stability of the microorganisms under industrial and physiological conditions , which their formulations accomplish ([0007]-[0010]). Shimoni teaches that the compositions comprise probiotic microorganisms encapsulated with a matrix comprising a combination of one or more disaccharide or oligosaccharide sugars , e.g. trehalose , and one or more dextrins , including maltodextrin ([0009], claims 52 and 54) . Shimoni suggests that these probiotic compositions have improved viability and are more stable during production and during prolonged storag e ( [0008]- [00 10 ], and FIG. 2, see [0022]). Regarding claims 11 and 15, Shimoni teaches blending maltodextrin with freeze-dried probiotic bacteria or in a probiotic formulation comprising freeze-dried probiotic bacteria to form a blend ( e.g. [00 19 ] and [012 3 ]- [012 4 ] , Example 4 ) and measuring viability of the blends ( see Example s 4 and 7 ) , wherein said maltodextrin has a dextrose equivalent (DE) between 17 and 23 (see e.g. Table 4, [0127 ] : “ Four specific formulations were selected for exemplifying the viability of the probiotics within the composition of the invention during storage ”, which includes m altodextrin DE19 , see FIG. 2B ) . Shimoni also teaches testing the long-term stability of compositions including those with maltodextrin DE19 (FIG. 2B), and demonstrates that the probiotic bacteria maintain high levels of viability after more than 40 days of storage at 4°C with maltodextrin DE19 (see Example 7, [0127]-[0129]). The full suitable range taught for the maltodextrin dextrose equivalent (DE) is 2 to 30 ([0044]; claim 67). Shimoni also teaches that formulations of the probiotic bacteria have a water activity (AW or a w ) in some embodiments which is less than 0.1 and as low as 0.01 ( [0066]- [0067] ). Shimoni teaches a number of compositions having maltodextrin DE19 and various a w including several near 0.1 or below (as demonstrated in Table 3). Shimoni teaches that adjusting the water activity of such products to desired amounts is known in the art ( [0123] : “ frozen particles were further freeze dried by conventional freeze-drying equipment for 24-72 hours (depending on desired water activity of the product ”). Regarding claim 15 and claims dependent thereof, S himoni teaches that the composition may be in the form of a powder, and teaches various powder particle sizes ([0089]). Regarding claims 13, 14, 20, and 21, Shimoni teaches preferred probiotic organisms (i.e. organism s with a potential health benefit to a subject ) to provide include, inter alia , the microorganisms B ifidobacterium animalis subsp . l actis , e.g. Bifidobacterium lactis , and Lactobacillus acidophilus ([0034]-[0035]). Regarding claims 24-26, the examples taught in Shimoni includes compositions comprising maltodextrin DE19 , thus the reference teaches using maltodextrin with a dextrose equivalent between 19 and 20. Regarding claim 27, specific embodiments in Shimoni include compositions with maltodextrin DE19 having a w a below 0.09, specifically Shimoni teaches two such compositions having w a of 0.044 and 0.078 (rows 2 and 7 of Table 3, [0122]). Shimoni does not explicitly teach a single embodiment wherein a maltodextrin is mixed with a freeze-dried probiotic bacteria having all of the recited properties, including a water activity (AW) below 0.1 and a dextrose equivalent (DE) between 17 and 23 . However, the reference does teach and/or reasonably suggest all of the limitations of the instant claims. Therefore , to one of ordinary skill in the art, prior to the effective filing date of the instant invention, it would have been prima facie obvious in view of the teachings of Shimoni to produce a freeze-dried probiotic bacterial composition having maltodextrose with a dextrose equivalent (DE) around 19 and a water activity ( a w ) of 0.1 or less for the express purpose of producing a freeze-dried probiotic bacteria product having viability and long-term stability. One would have been motivated by the teachings of Shimoni to provide a freeze-dried probiotic bacterial composition having maltodextrose with a dextrose equivalent (DE) around 19 and a water activity (a w ) of 0.1 (or around 0.1) because the reference teaches such compositions in dry forms capable of maintaining high viability and long-term storage stability (i.e. shelf life). Further, adjustments of water activity ( a w ) in these compositions is known in the art, as evidenced by Shimoni , to be a result-effective variabl e , such residual moisture affecting the time for freeze-drying and the stability of the preserved organisms. One of ordinary skill would have been motivated and capable of optimizing the preservation methods taught in Shimoni through routine optimization to arrive at a method for providing such dried bacteria with maltodextrin having the instantly claimed DE and water activity, see MPEP § 2144.05 . T he determination of suitable or effective concentration and characteristics of a known composition , or performing a known method to the art, can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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). In the instant case, optimizing the water activity of freeze-dried probiotic compositions amounts to routine optimization of the amount of water remaining, and there is no convincing evidence in the instant specification of unexpected results when using the claimed values. Regarding claims 13 -1 4 and 20 -2 1, the providing of Bifidobacterium lactis and /or Lactobacillus acidophilus would have been a matter of judicious selection from known useful probiotic bacteria, because these were exemplary probiotic bacteria taught in Shimoni . Regarding claims 24-2 7, these additional limitations are all taught and/or disclosed by the cited teachings of Shimoni discussed above. Shimoni explicitly teaches freeze-dried probiotics with maltodextrin DE19, and also teaches embodiments wherein the a w is less than 0.09. Arriving at such claimed methods for improving bacteria stability would have thus been prima facie obvious for all of the reasons described above. From the teachings of the cited Shimoni reference , it is apparent that there would have been a reasonable expectation of success in providing the materials for improving stability (e.g. shelf life) of a probiotic product, because the cited teachings demonstrate that these compositions have stability over a period of more than 40 days and maintain viability. Further, the cited reference establishes that manipulation of water activity to a desired amount is known to the art. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date , as evidenced by the cited references, especially in the absence of evidence to the contrary. Claims 7-8, 11, 13-15, and 20-27 FILLIN "Pluralize claim, if necessary, and then insert the claim number(s) which is/are under rejection." \d "[ 1 ]" are rejected under 35 U.S.C. 103 as being unpatentable over Shimoni et al. (US PGPub No. 20100189767), as applied to claims 11, 13-15, 20-21, and 24-27 FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" above, and further in view of Weill et al. (US PGPub No. 20130156739 ). The teachings of Shimoni are discussed above, and include all the limitations of claims 11, 13-15, 20-21 and 24-27. However, Shimoni does not teach nor reasonably suggest that the maltodextrin is combined with a base, including one of the specific bases KOH, NaOH, or NH 4 OH, as recited in claims 7-8 and 22-23. Weill et al. (US PGPub No. 20130156739 ) pertains to a p roduct to be administered orally, for example as food or food supplement , which comprises a base product and several agents that provide benefits to the upper gastric sphere , including addressing acidity and disorders of the upper digestive tract (Abstract; [0001] -[0003] ). The composition taught in Weill comprises “maltodextrin gum”, obtained by partial hydrolysis of starch , ([0082]-[0084]), and teaches that such maltodextrin has a dextrose equivalent of 3 to 20 ([0083]). Regarding the addition of bases to maltodextrin, Weill teaches that the compositions comprises mineral salts and a base anion used to increase the pH of the composition ([0097] -[0098] ) , and that the mineral salt is preferably a sodium salt, a calcium salt, an aluminum salt, a magnesium salt, or a mixture thereof ([0099]). Specific species of the bases taught in Weill include sodium hydroxide, recited as an alternative in the instant claims 8 and 22. Weill teaches that compositions includes a matrix can further comprise microorganisms ([0051]) , such as lactic acid bacteria and/or probiotics , wherein the probiotics can be lactic acid bacteria , including many of the same bacteria discussed as preferable for the instant invention (see [0125]: “... Bifidobacteria and Lactobacilli, such as Bifidobacterium brevis, Lactobacillus acidophilus, lactobacillus casei, Bifidobacterium animalis , Bifidobacterium animalis lactis, Bifidobacterium infantis , bifidobacterium longum, lactobacillus casei, lactobacillus casei paracasei , lactobacillus reuteri , lactobacillus plantarum, lactobacillus rhamnosus ” ) . Therefore, it would have been obvious to one of ordinary skill in the art , before the effective filing date of the instant invention, to add a base to the probiotic storage compositions taught in Shimoni , for the predictable benefit of increas ing the pH of a product comprising lactic acid bacteria as taught in Weill. One would have been motivated to do so because Weill teaches that compositions comprising lactic acid bacteria and a base product are useful for oral administration because the composition with a higher pH has therapeutic benefits. Further, one having ordinary skill in the art would be knowledgeable in adjusting pH of compositions, including adding bases to achieve a desirable pH level. No specific pH level or concentration of the base is required of the claims , just that a base is added . T here is no convincing e vidence of the criticality of using one of the three specific claimed bases, NaOH, KOH, or NH 4 OH. MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition (or performing a known method) can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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). In the instant case, the optimization of pH through the addition of bases (including the use of any of the claimed compounds sodium hydroxide, potassium hydroxide, and ammonium hydroxide) is well known to the art, at least as evidenced by the teachings of Weill discussed above. There is no indication of unexpected results when modifying the pH of the bacteria combinations nor is there a recitation of achieving a specific pH level or desired result in the examined claims. From the teachings of the cited reference s , it is apparent that one of ordinary skill in the art woul
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Prosecution Timeline

Aug 01, 2023
Application Filed
Mar 28, 2026
Non-Final Rejection — §103, §112 (current)

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