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 .
DETAILED ACTION
This application is a CON of PCT/CN2022/092422, filed May 12, 2022.
Applicant’s Preliminary amendment filed December 10, 2024 is acknowledged. Claims 14-15 are canceled, claims 16-22 are newly added, and claims 1-13 are amended. Currently claims 1-13 and 16-22 are pending and under examination.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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 7-8, 10, and 20 are objected to because of the following informalities:
Claim 7, line 2, needs to be changed to “…is discontinued before or when the infant is 6 months of age…” to remove superfluous language. The same correction applies to claim 8.
Claim 10, line 3, needs to be changed to “.
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 1-13 and 16-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites wherein the administration of the composition “increases the relative abundance” of Bacteroides, Parabacteroides, and combinations thereof. The term “relative abundance” is a subjective term, which is not defined in claim 1 or the specification. It is unclear whether the increase is determined by comparison of the infant’s intestinal microbiota before and after administration, by comparison of an untreated control, or by comparison with another reference population or time point. Accordingly, one of ordinary skill in the art would not be apprised of when administration satisfies the recited increase, and therefore the metes and bound of claimed method. Furthermore, it is unclear the measurement of ‘increase in relative abundance’ for the recited bacteria, such as if Bacteroides increases in sequenced bacterial reads, but if it’s absolute abundance remains unchanged due to other organisms decline, then there is ambiguity as to how ‘increase in relative abundance’ is assessed.
Claim 2 recites “wherein the relative abundance is increased to a level of relative abundance as observed in the intestinal microbiota of a vaginally born infant.”, which fails to provide reasonably clear boundaries as to the required level of relative abundance. The claim does not identify a particular vaginally born infant, reference population, age or sampling time, or numerical value or range to which the relative abundance is compared. The intestinal microbiota varies among vaginally born infants and over time, thus it is unclear whether the limitation encompasses any level observed in any vaginally born infant, an average or typical level among vaginally born infants, or the level observed in a particular reference or control population.
Claim 4 recites “wherein the increase in relative abundance is observed when comparing to the level of relative abundance in the intestinal microbiota of an infant born by Caesarean section that received a nutritional composition without Bifidobacterium breve.”. The claim is indefinite because it does not define a particular comparator infant or control population, nor does it define the nutritional composition administered to the comparator other than by the absence of B. breve, such as if the nutritional composition is compositionally different from the composition recited in claim 1.
Claim 5 recites the limitation "the nutritional composition" in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, the same recited limitation lacks antecedent basis in claims 12-13 and 21-22.
Claim 6 recites the limitation "the effect" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation “the effect” is not clearly defined in relation to claim 1, and is unclear whether “the effect” means the increase in Bacteroides and/or Parabacteroides as required by claim 1, or encompasses some other effect on the relative abundance of bacteria generally. The same issue applies to “the effect” recited in claims 7 and 18. Furthermore, it is unclear how the effect due to administration of the composition is determined when observed at an age of 8 months or older.
The term “comparable to” in claim 8 is a relative term which renders the claim indefinite. The term “comparable to” 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. The claim does not provide an objective standard for determining what degree of similarity in relative abundance constitutes ‘comparable’, nor does the claim clearly identify the ‘reference’ infant or reference population against which the comparison is made.
Claim 8 recites the limitation "the reference healthy vaginally delivered infant" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Furthermore, “healthy vaginally delivered infant” is a subjective term which
Claims 7-8 recite
Dependent claims 9-11, 16-17, and 19-20 are likewise rejected as being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 13 and 22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites “wherein the increase in relative abundance is observed when comparing to the level of relative abundance in the intestinal microbiota of an infant born by Caesarean section that received a nutritional composition without Bifidobacterium breve.”, but does not further limit the method claim recited in claim 1, merely reciting the desired effect as compared to an infant born by cesarean section receiving the composition without B. breve.”, which does further limit the infant to whom the claimed composition is administered or the composition administered thereto.
Claim 13 recites wherein the nutritional composition comprises partially hydrolysed proteins; and claim 22 recites wherein the nutritional composition comprises partially hydrolysed whey protein. Claims 13 and 22 depend upon claim 1 that recites administering a composition comprising B. breve and non-digestible oligosaccharides, not administering a “nutritional composition”, thus claim 13 and claim 22 do not further limit the composition administered in the method of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-13, and 16-22 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Nutricia (WO 2017/043962 A1, cited in IDS filed 11/11/2024).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1-2, 4, 6, 9, 12, 16-19, and 21, Nutricia teaches a method for stimulating microbiota health after non-natural birth, i.e. delivered via C-section, with a composition comprising a therapeutically effective amount of Bifidobacterium breve and at least one non-digestible prebiotic oligosaccharide (title, abstract, pg. 4, line 5). Nutricia teaches the non-digestible oligosaccharide are selected from the group consisting of fructo-oligosaccharide (including fructopolysaccharides such as inulin, a long-chain fructo-oligosaccharide, lcFOS), non-digestible dextrin, galacto-oligosaccharide (GOS), xylo- oligosaccharide, inter alia (pg. 8, lines 31-32). Nutricia teaches the formula carried out in the method comprised scGOS/lcFOS (about 9: 1 weight ratio) (0.8g/100ml) and B. breve M-16V (7.5x 108 CFU/l00ml) (pg. 16, lines 8-9). As disclosed in the Specification, the composition administered to the C-section infants comprised galacto-oligosaccharides and long chain fructo-oligosaccharides, as well as B. breve M-16V strain of the claimed method (pg. 9, para 3). Although Nutricia is silent as to the composition administered increasing relative abundance of Bacteroides, Parabacteroides, or combinations thereof, the property of administering the same composition in the same process taught in the prior art and claimed in the instant would inherently function the same, and would result in the increased relative abundance of the bacteria of the infant’s microbiota. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus, claims 1-2, 4, 6, 9, 12, 16-19, and 21 are anticipated by Nutricia.
Regarding claims 5 and 7-8, Nutricia teaches the composition used in the method was administered from birth until age 16 weeks (pg. 16, line 10), thus anticipates the limitations of administering to an infant 0-6 months of age, and discontinuing the administration at the latest when the infant is 6 months of age. The limitation of ‘effecting’ the relative abundance of Bacteroides would be an inherent property of the composition and method taught in the prior art as discussed in MPEP § 2112.01, thus anticipates the claims.
Regarding claim 10, Nutricia teaches the supplement according to the invention may contain the probiotics (i.e. B. breve) in an amount of 107 to 1013 cfu/g, or more suitably 1010 to 1012 cfu/g, based on dry weight of the supplement, which falls within the range recited in the claim (pg. 8, lines 10-13).
Regarding claims 11 and 20, Nutricia teaches the present composition suitably comprises 0.05 to 20 wt% of said non-digestible oligosaccharides, more suitably 0.5 to 15 wt%, even more suitably 1 to 10 wt%, most suitably 2 to 10 wt%, based on dry weight of the present composition, which anticipates the claims (pg. 9, lines 30-33).
Regarding claims 13 and 22, Nutricia teaches the composition comprises whey protein, and the proteins may be intact or hydrolysed or a mixture of intact and hydrolysed proteins, thus anticipating the claims (pg. 11, lines 20, 31-33).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nutricia as applied to claims 1-2, 4-13, and 16-22 above, and further in view of Lay et al. (WO2019/115382 A1, cited in IDS filed 11/11/2024, hereinafter “Lay”).
As discussed above, Nutricia anticipates claims 1-2, 4-13, and 16-22. Nutricia does not disclose the infant in the method is an infant whose mother received antibiotics during delivery.
However, Lay teaches a method for improving or stimulating the development of a healthy gut microbiota, by stimulating Bifidobacterium intra-species growth, in infants born with a lack of Bifidobacterium species at birth, preferably in infants whose mothers received antibiotics during delivery and/or in infants delivered via C-section (abstract). Lay teaches a composition comprising B. breve and non-digestible oligosaccharides administered to infants whose mothers received antibiotics during delivery and/or in infants delivered via C-section, resulted in restoring bifidobacteria levels within the first days of life, and therefore promotes a healthy gut microbiota in the infant [0005, 0009-0010].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Nutricia of administering a composition comprising B. breve and non-digestible oligosaccharides to an infant born by cesarean as taught by Nutricia, and also administer the composition to an infant whose mother received antibiotics during delivery and delivered via C-section as taught by Lay. One of ordinary skill in the art would have been motivated to administer the composition taught by Nutricia to an infant whose mother received antibiotics during delivery to effectively establish bifidobacteria populations which are indicative a healthy infant gut microbiota as disclosed by Lay.
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 1-5, 6, 9, 12, 16-19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 and 22-30 of copending Application No. 18/638747 (reference application) in view of Long et al. (Frontiers in Microbiology, 2021, vol. 12, art. 691312, pgs. 1-13, cited in IDS filed 11/11/2024, hereinafter “Long”).
Regarding instant claims 1-4, 6, 9, and 16-19, claims 16-17, 22-25, and 29-30 of ‘747 recite a method for improving gut microbiota in an infant comprising administering a nutritional composition comprising galacto-oligosaccharides, fructo-oligosaccharides, beta-casein, and B. breve, wherein the infant is born via caesarean section or to an infant whose mother received intrapartum antibiotics. ‘747 does not recite the method results in increasing the relative abundance of Bacteroides and/or Parabacteroides in the intestinal microbiota.
However, Long teaches the influence of Cesarean section (CS) on the composition and development of gut microbiota during the first 3 months of life, and teaches in comparison with vaginally delivered (VD) infants, infants born by CS showed decreased relative abundance of Bacteroides and Parabacteroides and enrichment of Clostridium_sensu_stricto_1, Enterococcus, Klebsiella, Clostridioides, and Veillonella (abstract). Long teaches CS can lead to short-term and long-term health effects for children with the absence of transmission from maternal microbiota to offspring (pg. 2, col. 1, para 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of improving gut microbiota in an infant born by CS by administering a composition comprising galacto-oligosaccharides, fructo-oligosaccharides, beta-casein, and B. breve as recited in ‘747, to increase the relative abundance of Bacteroides and/or Parabacteroides which are markers of healthy intestinal microbiota of vaginally delivered infants as taught by Long with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to administer the composition comprising the oligosaccharides and B. breve to improve the gut microbiota of CS delivered infants, as the reduced abundance of Bacteroides due to CS delivery is taught in the art, and it would be reasonable that administering the composition to improve gut microbiota would also increase Bacteroides species, which are hallmarks of species in healthy vaginally born infants.
Regarding instant claim 5, claim 25 recites the infant is aged between 0-24 months, thus encompassing the range recited in the claim.
Regarding instant claims 12 and 21, claim 28 of ‘747 recite the composition is an infant formula, a follow on formula inter alia, thus meets the limitation of the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 16-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 and 22-30 of copending Application No. 18/638747 (reference application) in view of Long and Nutricia (WO 2017/043962 A1).
As discussed above, instant claims 1-5, 6, 9, 12, 16-19, and 21 were obvious over ‘747 in view of Long.
Regarding instant claims 7-8, ‘747 does not teach administration to the infant is discontinued at the latest when the infant is 6 months of age, and the effect on the relative abundance of Bacteroides is observed after 4 months or when the infant has reached an age of 8 months or older.
However, Nutricia teaches the composition used in the method was administered from birth until age 16 weeks (pg. 16, line 10), thus meets the limitations of discontinuing the administration at the latest when the infant is 6 months of age. Long teaches vaginally delivered infants had significantly higher relative abundance of Bacteroides than CS delivered infants when evaluated from 0-3 months, however CS infants’ Bacteroides’ abundance began to increase starting at 2 months, and discloses the first 3 months of early life is the first peak of growth and development and establishing a healthy microbiota (pg. 6, Figure 3B, pg. 2, col. 2, para 2).
Therefore, it would have been prima facie obvious to modify the method of improving infant gut microbiota by administering a composition comprising B. breve and oligosaccharides as recited in ‘747 and taught by Nutricia, and discontinue administration before 6 months of age as taught by Nutricia. One of ordinary skill in the art would have been motivated to modify the method of discontinuing administration before 6 months of age in the method recited in ‘747, since the first 3 months of life are the crucial time period of growth and development for establishing a healthy microbiota as taught by Long.
Regarding instant claims 10-11, 13, 20, and 22, claim 28 of ‘747 recites the composition is an infant formula, but does not recite the level of B. breve CFU/g dry weight of the composition, nor the weight% amounts of the non-digestible oligosaccharides in the composition, nor the composition comprises partially hydrolysed whey protein.
However, Nutricia teaches the supplement according to the invention may contain the probiotics (i.e. B. breve) in an amount of 107 to 1013 cfu/g, or more suitably 1010 to 1012 cfu/g, based on dry weight of the supplement, which falls within the range recited in the claim (pg. 8, lines 10-13). Likewise, Nutricia teaches the present composition suitably comprises 0.05 to 20 wt% of said non-digestible oligosaccharides, more suitably 0.5 to 15 wt%, even more suitably 1 to 10 wt%, most suitably 2 to 10 wt%, based on dry weight of the present composition, which meets the claims (pg. 9, lines 30-33). Nutricia also teaches the composition comprises whey protein, and the proteins may be intact or hydrolysed or a mixture of intact and hydrolysed proteins, thus meets the claims (pg. 11, lines 20, 31-33).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method for improving infant gut microbiota by administering a composition comprising B. breve and non-digestible oligosaccharides as recited in ‘747, and formulate the composition with the specified concentrations of B. breve and oligosaccharides, as taught by Nutricia with a reasonable expectation of success. Further it would have been prima facie obvious to further include partially hydrolysed whey protein in the composition recited in ‘747, since this is a common protein source in infant formula based on cow milk as taught by Nutricia (pg. 11, lines 19-20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
Prosecution Insights