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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
DETAILED ACTION
The amendment filed 12/29/2025 is entered. Claims 1-3, 5, 7-13, 15, and 20 are cancelled. Claims 4, 6, 14, 16-19 and 21-25 are pending and under consideration in this office action.
Priority
The instant claims are entitled to an effective filing date of 06/22/2018.
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 4, 6, and 22-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more. Each step described below is in reference to the subject matter eligibility test for products and processes (MPEP 2106).
Claim 4 is drawn to a composition of matter, which is one of the statutory categories (Step 1: Yes).
Claim 4 recites a composition comprising at least 107 heat-inactivated cells of a Bifidobacterium bifidum strain SYN-HI-001. Claim 4 is a product-by-process claim because heat-inactivation is a method step by which the bacteria are inactivated or killed. MPEP 2113(I) states that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In the instant case, there is no structural distinction of record between the instantly claimed heat-inactivated B. bifidum strain SYN-HI-001 and naturally occurring dead B. bifidum. As evidenced by Luyt (provided with the action mailed 10/30/2024), Bifidobacterium are inhabitants of the human microflora that naturally die. See page 2 paragraph 2 lines 5-7, and the last 4 lines of page 2. Furthermore, evidentiary reference Harris (provided with the action mailed 12/18/2023) discloses that Bifidobacterium are naturally sensitive to heat, and require refrigeration to survive. See paragraph 2 under the “heat” section on 4. According to Rerksuppaphol (provided with the IDS filed 12/17/2020), when a composition comprising lyophilized live Bifidobacterium bifidum is stored at 37ºC the stability is only 2 weeks and the amount of live microorganisms’ is reduced by 50% during that time. See the paragraph spanning 299 to 300. Thus, the application of heat to render bacteria non-viable is a naturally occurring consequence of expositing the bacteria to any source of heat, and the number of cells inactivated by the heat may increase over time. Therefore, the composition of claim 4 entails non-viable or dead B. bifidum, which is a nature-based product judicial exception.
This judicial exception is not integrated into a practical application because claims 4, 6, and 22-24 fail to add any significant elements beyond the nature-based product. Claim 4 requires that the composition to comprise B. bifidum strain SYN-HI-001, wherein at least 98% of the B. bifidum strain SYN-HI-001 cells are heat-inactivated. This limitation to does not amount to significantly more than the judicial exception because B. bifidum naturally die when exposed to heat for a prolonged period of time, such that the percentage of dead cells increases over time. Besides the natural product, claim 1 requires the composition to be in a form selected from a list that includes capsules, solutions, suspensions, powders and granules. There is no evidence of record that those forms impart a markedly different characteristic to the natural product and capsules merely house the natural ingredients. The instant specification discloses that an aqueous suspension of the non-viable bacteria may be formed by combining diluents, such as water, and sweetening agents. See the last full paragraph on page 13 of the specification filed 12/17/2020. The additional water and sweetener elements in the solution do not impart a markedly different characteristic to the natural product, so the instantly claimed solution form, for example, does not integrate the natural product into a practical application. Furthermore, the instant specification does not distinguish the instantly claimed powder and granule forms from the dry powder of inactivated bacteria alone. See the lines 26-27 on page 18. As such, the capsules, solutions, suspensions, powders and granules for reconstitution and dispersible powders and granules forms recited in claim 1 do not integrate the natural product into a practical application because the forms do not significantly limit the natural product or clearly add an element beyond the structure of the natural product alone. Claim 6 does not structurally limit the composition in anyway. Rather, claim 6 merely serves to link the natural product to its field of use as a pharmaceutical composition or a food composition. Claim 22 requires at least 99% of all present B. bifidum SYN-HI-001 bacteria to be heat inactivated. Claim 23 requires at least 99.9% of all present B. bifidum SYN-HI-001 bacteria to be heat inactivated. The limitations of claims 22-23 do not add any elements to the natural product judicial exception that could integrate it into a practical application, because claims 22-23 encompasses the natural product comprising 100% heat-inactivated B. bifidum alone. Claim 24 requires the composition to be in the form of capsules. Claim 25 requires the composition to be in the form of a capsule, and wherein the heat-inactivated bacteria are in a dry powder form contained in the capsule. The additional capsule element of claims 24 and 25 do not integrate the judicial exception into a practical application because the capsule element is an insignificant or nominal addition that is tangential to the primary composition comprising heat-inactivated B. bifidum. Furthermore, there is no evidence of record that the capsule element confers a markedly different characteristic to the natural product as a capsule merely houses the natural product, i.e. the heat-inactivated bacteria in a dry powder form. Accumulatively, the additional limitations in claims 4, 6 and 22-24 do not impose any meaningful limitation over the nature based judicial because the additional claimed elements are either insignificant (relevant to instant claims 4 and 24), or the additional limitations only serve to generally link the product of nature to a particular technological environment (relevant to instant claim 6). Therefore, the claims as a whole do not integrate the judicial exception into a practical application (Step 2A Prong 2: No)
The additional elements fail to amount to an inventive concept in view of the well-known and conventional practices in the art of probiotic pharmaceuticals. Capsule formulations with inactivated or dead B. bifidum were well known in the art at the time of filing. For example, Aureli (International Journal of Food Microbiology, 137(2-3), 265-273, 2010) teaches analyzing commercially available probiotic preparations in forms selected from a list that includes capsules, tablets and powder sachets. See section 2.1. According to Aureli, most supplements labelled as including B. bifidum have dead cells. See the abstract, section 3.2 and the third paragraph in the right column on page 270. Furthermore Goderska (Polish Journal of Microbiology, 57(2), 135, 2008) teaches encapsulating Bifidobacterium bifidum in a starch solution, spray-drying the starch solution at an air temperature of 185ºC at an inlet of an atomizer and 85ºC at the outlet, then determining the number of live bacteria in 1g of spray-dried capsules. See the left column on page 136 and the second paragraph in the right column on page 136. As shown in figure 2 the number of living bacteria decrease, which indicates the presence of inactivated B. bifidum. Thus, the additional insignificant capsule element in claims 4 and 24 fail to amount to an inventive concept (Step 2B: No).
For all of these reasons, claims 4, 6, and 22-24 are not patent eligible.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are unpersuasive.
§ 101 rejection
Applicant argues that the mixture of claim 4 results in a composition having unexpected and markedly different structural and functional characteristics and thus, is not a product of nature. See paragraphs 3-4 on page 4 of the remarks. Applicant references the declaration under 37 C.F.R. 1.132 filed 12/29/2025 to assert that that the at least 98% purity of the heat-inactivated SYNHI-001 ensures predictability and efficacy of the composition. Applicant further references Andresen (provided with the action mailed 12/18/2023), which states that “[t]he efficacy of various bacterial strains for the treatment of IBS is highly strain specific” and may differ in their efficacy and related properties such as adhesion to Caco-2 cells (right column page 659). See the third bullet on page 5 of the remarks.
The declaration filed 12/29/2025 will be addressed separately below. To the extent that Applicant is arguing that the specific SYNHI-001 strain is markedly different compared to other strains, it is not persuasive because such comparison is not germane to the analysis discussed above. The specification discloses that B. bifidum are one of the major genera of bacteria that make up the colon flora in mammals. See the first passage on page 4 of the specification filed 12/17/2020. There is no teaching or suggestion in the instant specification that the claimed heat-inactivated SYNHI-001 strain is structurally or functionally changed, compared to naturally occurring dead B. bifidum. MPEP 2106.04(c)(II)(C) states that “in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart”
Applicant references Andresen, which states that “[n]otably, following gentle heat inactivation, the B bifidum strain heat-inactivated (HI)-MIMBb75 (SYN-HI-001) has been rendered non-viable but still morphologically intact, and has preserved (and even increased) its Caco-2 cell-adhesive properties (unpublished)” (see the right column on page 659). Applicant asserts that this evidence supporting the different structural and functional characteristics rise to the level of a marked difference, as activity was shown to surpass the effects observed with the viable forms. See first passage on page 6 of the remarks.
This argument is not persuasive because the natural counterpart discussed in the analysis above is dead B. bifidum and not viable forms thereof. Andresen compares the Caco-2 cell-adhesive properties of heat-inactivated SYN-HI-001 to viable SYN-HI-001. However, Andresen is silent regarding a comparison between heat-inactivated SYN-HI-001 and dead B. bifidum. As such, the argument is not persuasive because Applicant has not pointed to a specific structural or functional distinction between the claimed heat-inactivated strain and its natural counterpart.
The examiner acknowledges receipt of the Declaration under 37 CFR 1.132 by Dr. Gschwender filed on 12/29/2025.
The declaration under 37 CFR 1.132 filed 12/29/2025 is insufficient to overcome the rejection of claims 4, 6, and 22-24 based upon § 101 as set forth in the last Office action because: the arguments presented therein are not commensurate in scope with the claims and the declaration fails to set forth facts, as discussed in depth below.
Dr. Gschwender asserts that a homogeneous pool of heat-inactivated bacteria of a single strain of bacteria ensures consistent activity. In contrast, dead bacteria in nature would be heterogeneous. This heterogeneity would impair the ability of the bacteria to adhere to the intestinal epithelium, thereby compromising their therapeutic effectiveness. Dr. Gschwender references Andresen (2020), as provided with the action mailed 12/18/2023. See the paragraph spanning pages 2-3 of the declaration filed 12/29/2025.
This argument is not persuasive because it is not commensurate in scope with the claims. Claim 4 recites the open-ended term “comprising” in line 1. Therefore, the instant claims encompass heterogeneous mixtures of bacteria, and are not limited to a homogeneous pool of heat-inactivated bacteria.
Dr. Gschwender asserts that a concentration of at least 107 bacteria ensures an effective dosage is provided. Although single examples of heat-killed bacteria may exist in nature, there is no evidence that a concentration composition of a homogeneous pool of this single strain of bacteria exists in nature. Additionally, the use of low concentrations obtained from nature will result in ineffective/no activity. See number 6 on page 3 of the declaration. Furthermore, Dr. Gschwender asserts that the purity of at least 98% ensures reliability, predictability, and efficacy of the composition. With such a high purity of heat-killed bacteria, the composition has an unexpectedly improved safety profile and efficacy as compared to what could be found in nature. See number 7 on page 3 of the declaration.
This argument is not persuasive because MPEP 2106.04(c)(II)(C) indicates that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. There is no evidence of record indicating that the claimed heat-inactivated bacterial strain has a different effect compared to dead B. bifidum when at a concentration of at least 107 heat-inactivated cells. In other words, the concentration does not impart a markedly different characteristic to the natural product, and at most any effect associated with the concentration is additive, absent evidence to the contrary. Furthermore, the declaration refers to the “reliability, predictability, and efficacy of the composition”, but is silent as to why those qualities are of practical significance.
Dr. Gschwender references Andresen to assert that the effect of the non-viable bacterial strain appears to reach or even surpass the effects observed in response to the corresponding viable form (see the discussion section of Andresen). See number 8 spanning pages 3-4 of the declaration.
This argument is not persuasive, because the natural counterpart discussed in the analysis above is not viable B. bifidum. As such, Andresen’s comparison between non-viable and viable strains is not germane to the rejection. Furthermore, the section of Andresen referenced does not constitute as fact-based evidence of a marked difference.
Dr. Gschwender argues that the use of tablets, capsules, solutions, emulsions, suspensions, powders or granules ensures that the composition reaches the intended internal target, increasing the bioavailability. See number 9 on page 4 of the declaration.
This argument is not persuasive because the declaration does not set forth any evidence that such formulations impart a markedly different characteristic to the natural product and capsules merely house the natural ingredients.
Claim Interpretation
In claim 17, the term about is defined as ±10%. See page 19 line 13 of the instant specification.
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.
Claims 4, 6, 14, 16-19 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Guglielmetti (US 2014/0056852 A1), in view of Prioult (US 2012/0107290).
Regarding claims 4, 6 and 22-24, Guglielmetti discloses a strain of Bifidobacterium bifidum or a variant thereof for use as probiotic, in foodstuff and/or as a medicament for the treatment of a disease correlated with a functional disorder in the gastrointestinal tract or with undesirable gastrointestinal inflammatory activity, the strain being Bifidobacterium bifidum MIMBb75, deposited under DSM 24514 (i.e. the instantly claimed SYN-HI-001 strain), or a mutant or variant thereof. See claims 1-3. In example 3.1, Guglielmetti teaches recording the IBS severity daily for patients receiving B. bifidum MIMBb75 at a concentration of 1x109 cfu/capsule (e.g. pharmaceutical composition) a day for four weeks. See [0054]. As a result, B. bifidum MIMBb75 significantly improved global IBS symptoms. See [0075]. Guglielmetti teaches an embodiment where the cells of the strain, mutant or variant are viable or non-viable. With non-viable cell products preparation is simpler, cells may be incorporated easily into pharmaceuticals and storage requirements are much less limited than in the case of viable cells. Cells may be killed thermally. See [0011]. Guglielmetti teaches probiotic formulations with an ingestible carrier that is a capsule, tablet, powder or a food product. See claims 7-8. Guglielmetti teaches possible ingestible carriers may be selected from a list that includes granule, emulsion, solution, suspension and hard gelatin capsule. See paragraph [0033]. Although Guglielmetti teaches tablets, capsules, solutions, emulsions, suspensions powders and granules, Guglielmetti teaches these forms amongst a list of other alternative forms.
Guglielmetti does not teach a composition comprising at least 107 heat-inactivated cells (relevant to instant claim 4).
Prioult suggests that several lactobacilli and bifidobacteria show an enhanced ability to stimulate for example the production of pro-inflammatory cytokines by human cells after heat treatment. See [0017]. Prioult teaches a method for treating or preventing disorders related to compromised immune defense comprising administering a composition comprising probiotics rendered non-replicating by a heat treatment of at least about 70 ºC for at least about 3 minutes. See claim 1. The probiotic is selected from a group that includes lactobacilli and bifidobacteria. See claim 2. The composition is in a form selected from a group that includes pharmaceutical compositions. See claim 5. The composition contains an amount of non-replicating probiotics corresponding to about 104 to 1012 cfu per daily dose. See claim 8. The heat treatment of the probiotics results in rendering at least 95% of the probiotics non-replicating. See claim 12. Prioult teaches medicaments in the form of tablets and capsules. See [0049]. Prioult suggests that the use of live probiotics might be limited for immune-compromised customers due to a potential risk of developing bacteremia. See [0020]. Non-replicating probiotic micro-organisms have the advantage that they are far easier to handle than their live counterparts. Additionally they are far more storage stable and need less stringent packing conditions. See [0018].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the 1x109 cfu B. bifidum MIMBb75 DSM 24514 in the capsule of Guglielmetti with the same amount of the non-viable thermally killed B. bifidum MIMBb75 DSM 24514 cells taught by Guglielmetti in view of Prioult. In the process, one would arrive at a pharmaceutical capsule (relevant to instant claim 24) composition comprising 1x109 thermally killed cells B. bifidum DSM 24514, which is at least 107 heat-inactivated cells as instantly claimed, and includes 100% thermally killed non-viable cells, which is at least 98% heat-inactivated cells (relevant to instant claim 4), at least 99% heat-inactivated cells (relevant to instant claim 22), at least 99.9% heat-inactivated cells (relevant to instant claim 23). One would be motivated to replace the live probiotic with the non-viable thermally killed counterpart taught by Guglielmetti, because Prioult suggests that non-replicating probiotic microorganisms are easier to handle, more storage stable, and safer for immune-compromised customers. There would be a reasonable expectation of success because Guglielmetti demonstrates formulating a capsule with 1x109 cfu live B. bifidum MIMBb75 DSM 24514, and Prioult teaches capsule formulations, and bifidobacteria pharmaceutical compositions comprising non-replicating probiotics corresponding to about 104 to 1012 cfu per daily dose.
Regarding claims 14 and 21, Guglielmetti teaches administering 1x109 cfu/capsule of Bifidobacterium bifidum DSM 24514 to patients with mild to moderate irritable bowel syndrome (IBS). See [0054-0055]. Guglielmetti concludes that B. bifidum DSM 24514 effectively alleviates global IBS as well as improves individual IBS symptoms. Considering the high efficacy of B. bifidum DSM 24514 in IBS along with the good side effect profile, Guglielmetti suggests that B. bifidum (DSM 24514) is a promising candidate for IBS (e.g. a gastrointestinal disorder) therapy See [0085].
Regarding claim 16, Guglielmetti teaches using B. bifidum DSM 24514 for the treatment of a disease selected from a group that includes irritable bowel syndrome, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, pouchitis, post infection colitis, and diarrhea due to undesirable inflammatory activity. See claims 1-3.
Regarding claim 17, Guglielmetti teaches administering 1x109 cfu/capsule of Bifidobacterium bifidum DSM 24514 to patients with IBS once a day. See [0054-0055]. Guglielmetti discloses that the colony forming unit (cfu) is a measure of viable Bifidobacterium bifidum bacterial cells or mutant or variant thereof [0035]. The probiotic formulation comprises the strain, mutant or variant thereof at more than 101, optionally not less than 102 cfu per capsule [0035]. If the strain, mutant or variant comprises an ingestible carrier, such as a capsule of tablet or comparable ingestible carrier, the administration is performed orally [0035]. Furthermore, Guglielmetti teaches cells killed thermally [0011]. Thus, Guglielmetti teaches oral administration and a daily amount of at least about 105 live cells.
Prioult teaches a composition that may be administered orally, enterally, parenterally, topically or ocularly. See [0047]. Prioult teaches a method for treating or preventing disorders related to compromised immune defense comprising administering a composition comprising probiotics rendered non-replicating by a heat treatment of at least about 70 ºC for at least about 3 minutes. See claim 1. The probiotic is selected from a group that includes lactobacilli and bifidobacteria. See claim 2. The composition is in a form selected from a group that includes pharmaceutical compositions. See claim 5. The composition contains an amount of non-replicating probiotics corresponding to about 104 to 1012 cfu per daily dose. See claim 8. Thus, Prioult teaches oral administration and a daily dose of non-replication bacteria that overlaps with the instantly claimed at least about 105 heat-inactivated cell range.
Regarding claim 18, Guglielmetti teaches administering B. bifidum (DSM 24514) capsules to patients with IBS in example 3 [0055]. Furthermore, Guglielmetti defines a patient as a person or human or animal [0026]. Thus, Guglielmetti implies that the capsules of B. bifidum DSM 24514 are administered to human patients in example 3.
Prioult teaches administering a composition comprising probiotics that are rendered non-replicating by a heat treatment of at least about 70ºC for at least about 3 minutes to an individual in need. See claim 1. The individual is a human. See claim 7.
Regarding claim 19, Guglielmetti teaches administering the B. bifidum DSM 24514 to patients with IBS [0054-0055]. Guglielmetti discloses that the B. bifidum DSM 24514 may be used to treat autoimmune disorders due to undesirable inflammatory activity. See claims 1-3 and 10-11 and paragraphs [0018-0019]. Thus, Guglielmetti teaches an administration to immune-compromised subjects, such as those with IBS or with autoimmune disorders due to undesirable inflammatory activity.
Prioult teaches a method for the preparation of a composition for treating or preventing disorders related to a compromised immune defense comprising probiotics that are rendered non-replicating by a heat treatment of at least about 70ºC for at least about 3 minutes to an individual in need. See claim 1. The disorder is selected from the group consisting of infections, low severe immunodepression levels natural states of less immunocompetent immune system allergies, and combinations thereof. See claim 4.
Regarding claim 25, Guglielmetti teaches mixing dry powder bacteria [B. bifidum MIMBb75 DSM 24514] with a pharmaceutically acceptable compound and filling it into capsules of 1x109 cfu. See [0061].
Guglielmetti does not teach heat-inactivated bacteria in a dry powder form.
Prioult teaches rending probiotics non-replicating by heat treatment. See [0079]. Prioult teaches transferring a mixture of probiotics and water to a drying apparatus and converting it (i.e. the non-replicating probiotic) to powder. See [0080], [0083] and [0086]. Prioult teaches non-replicating probiotic microorganisms that allow the hot reconstitution, e.g., of powdered nutritional compositions. See [0021]. Prioult teaches a composition that contains an amount of non-replicating probiotics corresponding to about 104 to 1012 cfu per daily dose. See claim 8. Thus, Prioult teaches a method for converting non-replicating probiotics into a powder.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the live 1x109 cfu B. bifidum MIMBb75 DSM 24514 in the capsule of Guglielmetti with the same amount of the non-viable thermally killed B. bifidum MIMBb75 DSM 24514 cells taught by Guglielmetti in view of Prioult, as discussed above; and to further apply the powder conversion technique of Prioult to the non-viable thermally killed B. bifidum MIMBb75 DSM 24514 prior to encapsulation. One would be motivated to apply the powder conversion technique of Prioult to the non-viable thermally killed cells of Guglielmetti because Prioult suggests that non-replicating probiotic microorganisms are more storage stable, and safer for immune-compromised customers. Moreover, Prioult suggests that powdered probiotics may be useful for nutritional compositions. There would be a reasonable expectation of success because Prioult demonstrates converting non-replicating probiotics into a powder, and Guglielmetti demonstrates filling capsules with dry powder.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are unpersuasive.
§ 103 rejection
Applicant argues that the rejection relies on a POSITA expecting the probiotic formulations to Guglielmetti to be interchangeable with non-viable cells. However, the use of non-viable was unexpectedly found to be even more efficacious than the probiotic formulation. Applicant references paragraph 8 of the declaration filed 12/29/2025. See the last paragraph on page 6 of the remarks.
This argument is not persuasive because arguments of counsel cannot take the place of factually supported objective evidence (MPEP 2145 or 716.01(c)). See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Applicant has not pointed to evidence of an unexpected result. Paragraph 8 of the declaration filed 12/29/2025 does not set forth evidence of an unexpected result, and the paragraph is not germane to the obviousness rejection. Rather, paragraph 8 of the declaration references the discussion section of Andresen, and asserts that “[t]hese different structural and functional characteristics rise to the level of a marked difference” (relevant to the rejection under §101 discussed above). See the first passage on page 4 of the declaration filed 12/29/2025. Furthermore, the discussion section of Andresen does not provide fact-based evidence of an unexpected result. Andresen teaches that the non-viable bacterial strain appears to reach or even surpass the effects of the viable form (first passage in the right column on page 665). However, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, every claimed structural element is taught by the prior art of Gugliemetti and Prioult.
Applicant argues that Andresen teaches that a POSITA would not expect a non-viable strain to work therapeutically. For example, Andresen states that “inactivation of bacteria has repeatedly been found to decrease their efficacy” (right column page 660). Furthermore, Applicant asserts that Andresen teaches that IBS treatment efficacy is strain specific. Thus, even after the priority date of the present invention, a POSITA would not have expected that a heat inactivated, strain specific bacterium could be used therapeutically. See page 7 of the remarks.
This argument is not persuasive because Applicant has not pointed to a specific claimed element not taught by the combination of Gugliemetti and Prioult. Gugliemetti teaches the instantly claimed strain deposited under DSM 24514 (i.e. the instantly claimed SYN-HI-001 strain). See claims 1-3 of Gugliemetti. Furthermore, the referenced teachings of Andresen do not constitute as evidence of unexpected results.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/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, LOUISE HUMPHREY can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657