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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 8/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-10 are pending. Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-8 and 10 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 1/22/2025 and 2/14/2025 have been considered. Signed copies are enclosed.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 46. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-4 and 10 are objected to because of the following informalities:
Claims 1-2 and 10 contain the acronym CFU. While acronyms are permissible shorthand in the claims, the first recitation of the term should include the full recitation followed by the acronym in parentheses.
Claims 1-4 and 10 refer to “B. Infantis”. In scientific binomial nomenclature, it is appropriate to spell out the genus name in the first instance. Further, the species name should not be capitalized.
Appropriate correction is required.
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 1-8 and 10 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 pre-AIA the applicant regards as the invention.
Claims 1 and 10 are rendered indefinite by the phrase “comprising about 5 to about 15 billion CFU of B. Infantis”. It is not clear if applicant intended the range to be 5-15,000,000,000 or 5 billion to 15 billion. Though the claim recites 5-15,000,000,000, this does not make any sense as any person of any real skill in the art would realize that only 5 cells could not be expected to have any actual effect. This suggests that applicant intended the range to be 5 billion to 15 billion.
Claim 1 is rendered indefinite by the phrase “wherein the method is clinically associated with a statistically significant reduction in the cumulative incidence of atopic dermatitis”. It is not clear if this is simply an expression of the outcome of the method or if this is actually a step that must be performed. It is not clear if one must make a comparison of the results of the administration to a control group. Further, it is not clear what constitutes a “clinical association”.
The term “ceramide-rich” in claims 1 and 10 is a relative term which renders the claim indefinite. The term “ceramide-rich” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 5 is rendered indefinite by the phrase “from three months of age”. There is no end date to this treatment. Therefore, it appears the invention would not be infringed if a practitioner were to stop administering the allergenic food at some point. It is not clear if this is what applicant intended.
Claims 7 and 8 are rendered indefinite by the phrase “reduction in the risk of the cumulative incidence”. It is not clear what this phrase means. It is likely applicant is referring to a reduction in the cumulative incidence, but it is not clear what the risk of incidence is. Further, it is not clear if this is simply an expression of an outcome or how someone would achieve these specific numbers. Furthermore, one could not know whether they had practiced the method until after they had done it.
Claim 10 is rendered indefinite by the phrase “wherein the treated population of infants demonstrates a statistically significant reduction in the cumulative incidence of atopic dermatitis at 12 months or at 52 weeks, as compared to a control population of infants”. It is not clear if this is simply an expression of the outcome of the method or if this is actually a step that must be performed. It is not clear if one must make a comparison of the results of the administration to the control group.
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 1-4, 7-8, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of copending Application No. 18/038,519 in view of Hourihane et al (Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants -- the STOP AD randomised controlled trial. Authorea. April 08, 2022 DOI:10.22541/au.164940311.12725370/v1).
The instant claims are drawn to methods of treating infants identified at high risk of atopic dermatitis by administering B. infantis and a daily skin treatment with a ceramide rich emollient.
The copending claims are drawn to methods of preventing atopic dermatitis by administering B infantis to infants. The copending claims recite all of the limitations with regard to administration of B infantis.
The copending claims differ from the instant claims in that they do not recite skin treatment with a ceramide-rich emollient.
Hourihane et al disclose methos of preventing atopic dermatitis by treating infants with daily skin treatment with ceramide-rich emollient beginning on day 4 after birth (see abstract). The infants were identified as at high risk for atopic dermatitis and were treated for 8 weeks (see abstract).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use the method of Hourihane et al in conjunction with the method of the copending claims because it is obvious to combine equivalents known for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In addition, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418, 82 USPQ2d at 1396. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.
One would have had a reasonable expectation of success because the copending claims are presumed to be enabled to achieve the stated outcome and because Hourihane et al showed that their method worked.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of copending Application No. 18/038,519 in view of Hourihane et al (Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants -- the STOP AD randomised controlled trial. Authorea. April 08, 2022 DOI:10.22541/au.164940311.12725370/v1) and further in view of Nadeau (US Patent Application Publication 2020/0306368).
The instant claims are drawn to methods of treating infants identified at high risk of atopic dermatitis by administering B. infantis and a daily skin treatment with a ceramide rich emollient.
The copending claims are drawn to methods of preventing atopic dermatitis by administering B infantis to infants. The copending claims recite all of the limitations with regard to administration of B infantis.
The copending claims differ from the instant claims in that they do not recite skin treatment with a ceramide-rich emollient and they do not recite administration of food allergens.
Hourihane et al disclose methos of preventing atopic dermatitis by treating infants with daily skin treatment with ceramide-rich emollient beginning on day 4 after birth (see abstract). The infants were identified as at high risk for atopic dermatitis and were treated for 8 weeks (see abstract).
Nadeau discloses methods of treating allergic disease, including atopic dermatitis, by administering combinations of food allergens including peanuts and tree nuts, among others (see abstract and paragraph 0026).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use the method of Hourihane et al and Nadeau in conjunction with the method of the copending claims because it is obvious to combine equivalents known for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In addition, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418, 82 USPQ2d at 1396. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.
One would have had a reasonable expectation of success because the copending claims are presumed to be enabled to achieve the stated outcome and because Hourihane et al showed that their method worked.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12138286. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the limitations of the instant claims is expressly recited in the patented claims. Therefore, the claims are anticipated.
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 1-4, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04662619 (https://clinicaltrials.gov/study/NCT04662619?id=nct04662619&rank=1&a=2&tab=history; 12/18/2020) in view of Hourihane et al (Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants -- the STOP AD randomised controlled trial. Authorea. April 08, 2022 DOI:10.22541/au.164940311.12725370/v1; IDS filed 1/22/2025).
The instant claims are drawn to methods of treating infants identified at high risk of atopic dermatitis by administering B. infantis and a daily skin treatment with a ceramide rich emollient.
The clinical trial discloses methods of treating infants identified as at high risk of atopic dermatitis by administering B infantis (see title). Infants were administered 8x109 CFUs of B. infantis once daily for 12 weeks (see page 7).
The copending claims differ from the instant claims in that they do not recite skin treatment with a ceramide-rich emollient and they do not specify that the bacteria is mixed with breast milk of infant formula.
Hourihane et al disclose methos of preventing atopic dermatitis by treating infants with daily skin treatment with ceramide-rich emollient beginning on day 4 after birth (see abstract). The infants were identified as at high risk for atopic dermatitis and were treated for 8 weeks (see abstract).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use the method of Hourihane et al in conjunction with the method of the copending claims because it is obvious to combine equivalents known for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In addition, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418, 82 USPQ2d at 1396. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. It would have been obvious to mix the bacteria with either breast milk or infant formula because this is the simplest way to administer something to an infant.
One would have had a reasonable expectation of success because the copending claims are presumed to be enabled to achieve the stated outcome and because Hourihane et al showed that their method worked.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04662619 (https://clinicaltrials.gov/study/NCT04662619?id=nct04662619&rank=1&a=2&tab=history; 12/18/2020) in view of Hourihane et al (Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants -- the STOP AD randomised controlled trial. Authorea. April 08, 2022 DOI:10.22541/au.164940311.12725370/v1; IDS filed 1/22/2025) as applied to claims 1-4, 7-8, and 10 above, and further in view of Nadeau (US Patent Application Publication 2020/0306368).
Clinical Trial NCT04662619 (https://clinicaltrials.gov/study/NCT04662619?id=nct04662619&rank=1&a=2&tab=history; 12/18/2020) in view of Hourihane et al (Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants -- the STOP AD randomised controlled trial. Authorea. April 08, 2022 DOI:10.22541/au.164940311.12725370/v1; IDS filed 1/22/2025) is set forth above.
The clinical trial and Hourihane et al, as set forth above differs from the instant invention in that they do not disclose administration of food allergens.
Nadeau discloses methods of treating allergic disease, including atopic dermatitis, by administering combinations of food allergens including peanuts and tree nuts, among others (see abstract and paragraph 0026).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use the method of Hourihane et al and Nadeau in conjunction with the method of the copending claims because it is obvious to combine equivalents known for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). In addition, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418, 82 USPQ2d at 1396. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. It would have been obvious to mix the bacteria with either breast milk or infant formula because this is the simplest way to administer something to an infant.
One would have had a reasonable expectation of success because the copending claims are presumed to be enabled to achieve the stated outcome and because Hourihane et al and Nadeau showed that their method worked.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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