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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al (WO 2012/078030 A1) in view of Hougee et al (WO 2008/153391).
Regarding claims 1, 10 and 11, Ludwig et al. teach a nutritional composition that is an infant formula and is used in the treatment and/or prevention of colic for infants (p. 12 lines 6-9; p. 14 lines 14-21). Ludwig et al. teach the composition is preferably administered to infants 6 months of age or younger (p. 15 lines 25-29), and is administered daily for a period of preferably at least 4 weeks (p. 13 lines 6-11).
Ludwig et al. teaches that the nutritional composition comprises a fermented ingredient, preferably a fermented milk derived protein, wherein fermentation is by lactic acid bacteria including Streptococcus thermophilus (p. 6 lines 13-29; p. 7 lines 21-30). The nutritional composition comprises preferably 15-70% of the fermented protein comprising composition based on dry weight (p. 9 lines 6-9), encompassing and thereby rendering obvious the claimed range of fermented ingredient.
Ludwig et al. further teaches that the nutritional composition comprises preferably 0.2-1.0 wt.% of the sum of lactate and lactic acid based on dry weight, and wherein the sum of L-lactic acid and L-lactate is more preferably at least 90 wt.% based on the sum of total lactic acid and lactate (p. 9 lines 14-22). The ranges for lactic and lactic acid content, and L-lactic acid and L-lactate content taught by Ludwig et al. overlap and thereby render obvious the claimed ranges.
Ludwig et al. are silent as to the nutritional composition comprising galacto-oligosaccharides and fructo-oligosaccharides in an amount as claimed.
Hougee et al. teach the inclusion of non-digestible oligosaccharides in infant formulas in order to stimulate intestinal microbiota (p. 3, 2nd paragraph). Non-digestible oligosaccharides taught by Hougee et al. preferably include galacto-oligosaccharides and fructo-oligosacchardies (p. 10, 2nd and 3rd paragraphs), and Example 3 teaches 0.8 wt. % galacto-oligosaccharides and fructo-oligosaccharides (i.e., fructan) per 100 ml of a nutritional composition.
Therefore, it would have been obvious to have included an amount of GOS/FOS as claimed in the formula of Ludwig et al., as Hougee et al. speak to the beneficial effects provided by the presence of GOS/FOS in infant nutritional formulas. Further, the inclusion of the GOS/FOS would have required no more than routine experimentation, as the amounts of GOS/FOS claimed are consistent with the amounts reported in the prior art.
Regarding the method as reducing the incidence of colic as recited in claim 1, reducing the number of crying episodes in an infant as recited in claim 10, or decreasing the duration of crying in an infant as recited in claim 11, as colic in infants was known to be related to crying often and for long periods, the teaching by Ludwig to treat and/or prevent colic in infants would encompass or at least make obvious reducing the number of crying episodes in an infant as recited in claim 10 and decreasing the duration of the crying in an infant as recited in claim 11. Additionally, Hougee et al. teaches that the combination of Bifidobacterium breve (a lactic acid bacterium) and FOS/GOS has multiple benefits for the infant consumer (pp. 3-4). Given that the only active method step is the administering the nutritional composition to the infant, as the combination of prior art teaches the same active method step as claimed (i.e., administering), and given that the prior art teaches that the claimed ingredients provide many improvements in the health of the infant consumer, the prior art is considered to provide the same effects as the instantly claimed methods as an infant that was not suffering from many of the ailments that the prior art compositions are reported to relieve would in turn not be expected to suffer colic, and would also not be expected to cry as frequently as an infant in distress.
Regarding claim 2, Ludwig et al. teach the composition is preferably administered to infants 6 months of age or younger, which encompasses and thereby renders obvious the claimed 4 months or younger (p. 15 lines 25-29).
Regarding claim 3, Ludwig teaches that the nutritional composition comprises a fermented protein ingredient fermented by lactic acid bacteria including S. thermophilus, which results in the development of beta-galactosidase (page 7 lines 21-25). Ludwig et al. is silent as to the beta-galactosidase activity. However, Ludwig et al. teach the same preferred strains of S. thermophilus as taught in the instant specification for the preparation of the fermented milk material. Compare Ludwig et al. at p. 7 line 21-p. 8 line 2 with the instant specification at p. 8 lines 5-18. Therefore, where the instant specification reports that the beta-galatosidase activity is a result of the fermentation activity, the beta-galactosidase activity in the prior art is considered to meet the claimed range.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 4, Ludwig et al. teach the incubated (i.e., fermented) composition is subjected to a heat treatment to inactivate at least 90% of living organisms. This inactivation results in less post-acidification (p. 7 lines 1-5). Therefore, the final composition of Ludwig et al. continues to comprise S. thermophilus as the bacteria is inactivated subsequent to the fermentation, but not removed from the composition.
Additionally, Hougee et al. teach the presence of B. breve in their infant nutritional formula, and teach that the combination of B. breve and non-digestible oligosaccharides provides an enhanced effect on many different disorders (p. 3, 2nd paragraph). Therefore, it would have been obvious to have provided a composition comprising both S. thermophilus and B. breve based on the teachings of Ludwig et al. and Hougee et al. as both S. thermophilus and B. breve are lactic acid bacteria that are known to be included in infant formula compositions in order to impart beneficial effects to the infant consumer.
Regarding claim 5, Hougee et al. teaches that the composition comprises less than 103 cfu B. breve (i.e., lactic acid bacterium) per g dry weight of the composition (p. 3 3rd paragraph), falling within the claimed range. Therefore, it would have been obvious to have included an amount of lactic acid bacteria as claimed in the composition provided by the combination of Ludwig et al. and Hougee et al. as this amount of lactic acid bacteria is taught by Hougee et al. to have beneficial effects on the consumer of the formula (pp. 3-4).
Regarding claims 6 and 9, Ludwig et al. does not specifically teach the amount of S. thermophilus per g dry weight of the composition. However, Ludwig et al. does teach that the fermented ingredient is prepared according to example 7 of EP 778885 or example 6 of FR 2723960 (p. 7 lines 6-10). The instant specification points to the same examples for the preparation of the fermented ingredient in the instant specification (p. 7 lines 21-25). Therefore, given the composition of Ludwig et al. comprises an amount of fermented ingredient as claimed (see rejection of claim 16 above), the composition of Ludwig et al. is further considered to comprise an amount of S. thermophilus to meet claims 27 and 37 given the fermented ingredient in the composition of Ludwig et al. is made by the same process as the fermented ingredient in the instant invention.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 7, Ludwig et al. teach that the lactic acid bacteria is inactivated (p. 7 lines 4-7). Hougee et al. also teach that the B. breve (i.e., lactic acid bacterium) to be included in the infant formula composition is inactivated (p. 2 last paragraph).
Regarding claim 8, Ludwig et al. teach the composition in a powder form that is reconstituted with water (p. 12 lines 20-23).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,617,327 (‘327). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim administering a nutritional composition to an infant with an age of 6 months or younger, wherein the composition comprises: at least 10% dry weight of a protein fermented by lactic acid bacteria including Streptococcus thermophilus; 0.5-20% dry weight non-digestible oligosaccharides including fructo-oligosaccharides and galacto-oligosaccharides; 0.10-1.5% dry weight lactate and lactic acid wherein the sum of L-lactic acid and L-lactate is more than 50% of the sum or total lactic acid and lactate; and wherein the composition comprises 102-105 cfu living Streptococcus thermophilus per gram dry weight. As ‘327 claims a nutritional formula for administration to a human age 0-36 months and an infant encompasses a human at least the ages of birth to 12 months, the claims of ‘327 encompass administration of an infant nutritional composition as claimed. ‘327 claims compositional ranges overlapping those claimed and thus the claimed ranges are considered encompassed or at least obvious.
‘327 does not claim the method as reducing the incidence of colic as recited in claim 1, or crying episodes as recited in claim 10, or the duration of crying as recited in claim 11; the nutritional formula as an infant formula; the composition in the form of a powder as recited in claim 8.
Regarding the method as reducing the incidence of colic as recited in claim 1, or crying episodes as recited in claim 10, or the duration of crying as recited in claim 11, as the same active steps of administration of a nutritional formula to infant is claimed by ‘327 the same result would be expected. It is noted that a preamble is considered where it breathes life and breath into the claims. In the instant case, the preamble recites the effect of the claimed method, and as the same active method steps are recited in the claims of ‘327 the same effect recited in the preamble is expected absent any clear and convincing arguments and/or evidence to the contrary.
Regarding the nutritional formula as an infant formula, as ‘327 claims a nutritional formula for humans of an age up to 36 months and as the Examiner takes official notice that infants were known to primarily be feed breastmilk or formula in powdered or liquid form for nutrition in the first year of life, the claims of ‘327 encompass or at least make obvious the nutritional composition as a formula, including in known forms such as powdered form.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 10, 11 and 13 of U.S. Patent No. 9,617,327 (‘327) further in view of Buckley et al (WO 01/93915 A1) and Montgomery (US 4,617,190).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim administering a nutritional composition to an infant with an age of 6 months or younger, wherein the composition comprises: at least 10% dry weight of a protein fermented by lactic acid bacteria including Streptococcus thermophilus; 0.5-20% dry weight non-digestible oligosaccharides including fructo-oligosaccharides and galacto-oligosaccharides; 0.10-1.5% dry weight lactate and lactic acid wherein the sum of L-lactic acid and L-lactate is more than 50% of the sum or total lactic acid and lactate; and wherein the composition comprises 102-105 cfu living Streptococcus thermophilus per gram dry weight. As ‘327 claims a nutritional formula for administration to a human age 0-36 months, the claims of ‘327 encompass administration of an infant nutritional composition as claimed.
‘327 does not claim the beta-galactosidase activity as 0.2-4 U per dry weight of the composition as recited in claim 3, however Montgomery teaches that in reconstitutable milk powder, including infant milk, it was known to include about 0.5-500 units of beta-galactosidase (abstract, column 1 lines 5-16, column 2 lines 55-66, column 4 lines 38-45 and claim 21). Additionally, Buckley et al. teaches that in the administration of beta-galactosidase, including through formula, can improve colic in infants (abstract, page 3 lines 13-15, page 5 lines 13-14 and page 6 lines 4-6). It would have been obvious to one of ordinary skill in the art for the nutritional composition of ‘327 to comprise a known amount of beta-galactosidase, including about 0.5-500 U dry weight as shown by Montgomery, in order to enhance the infant composition by treatment and/or prevention of colic in view of Buckley.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 10, 11 and 13 of U.S. Patent No. 9,617,327 (‘327), further in view of Ludwig et al (WO 2012/078030 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim administering a nutritional composition to an infant with an age of 6 months or younger, wherein the composition comprises: at least 10% dry weight of a protein fermented by lactic acid bacteria including Streptococcus thermophilus; 0.5-20% dry weight non-digestible oligosaccharides including fructo-oligosaccharides and galacto-oligosaccharides; 0.10-1.5% dry weight lactate and lactic acid wherein the sum of L-lactic acid and L-lactate is more than 50% of the sum or total lactic acid and lactate; and wherein the composition comprises 102-105 cfu living Streptococcus thermophilus per gram dry weight. As ‘327 claims a nutritional formula for administration to a human age 0-36 months, the claims of ‘327 encompass administration of an infant nutritional composition as claimed.
Regarding the composition as comprising inactive lactic acid bacteria as recited in claim 7, ‘327 claims a fermented protein ingredient but is silent to the bacteria as inactivated as recited in claim 7. Ludwig teaches an infant formula comprising a milk protein fermented with bacteria which is formed by treatment with Streptococcus thermophilus optionally with Bifidobacterium breve, wherein at least 90% of the microorganisms are then inactivated in order to form less post acidification and a safer product which is especially important for feed for infants, and wherein procedures of EP 778885, particularly example 7 (which includes spray drying of the composition with the bacteria) and FR 2723960, example 6 are used (page 6 line 24 through page 7 line 10 and page 8 lines 4-10). It would have been obvious for the composition of ‘327 to specifically comprise inactivated lactic acid bacteria in order to form less post acidification and a safer product which is especially important for feed for infants in view of Ludwig.
Claims 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. US 12150466 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in both applications are directed to a method of reducing the incidence of colic in an infant, comprising administering daily for a period of at least 4 weeks to the infant between 0 and 6 months of age an infant formula composition, comprising: (a) about 40 (25) to about 60 wt. % of a milk-derived fermented ingredient based on dry weight of the composition; (b) about 0.4 to about 1.5 wt. % galacto-oligosaccharides and fructo-oligosaccharides based on 100 ml of the composition; and (c) about 0.3 to about 0.7 wt. % of the sum of lactate and lactic acid based on dry weight of the composition, wherein the sum of L-lactic acid and L-lactate is more than 95 wt. % based on the sum of total lactic acid and lactate; and wherein the milk-derived fermented ingredient is fermented by Streptococcus thermophilus and/or Bifidobacterium breve..
The claims in both applications are directed to a method of reducing the number of crying episodes per day in an infant, comprising administering daily for a period of at least 4 weeks to the infant between 0 and 6 months of age an infant formula composition, comprising: (a) about 40 (25) to about 60 wt. % of a milk-derived fermented ingredient based on dry weight of the composition; (b) about 0.4 to about 1.5 wt. % galacto-oligosaccharides and fructo-oligosaccharides based on 100 ml of the composition; and (c) about 0.3 to about 0.7 wt. % of the sum of lactate and lactic acid based on dry weight of the composition, wherein the sum of L-lactic acid and L-lactate is more than 95 wt. % based on the sum of total lactic acid and lactate; and wherein the milk-derived fermented ingredient is fermented by Streptococcus thermophilus and/or Bifidobacterium breve.
The claims in both applications are directed to a method of decreasing the duration of crying in an infant, comprising administering daily for a period of at least 4 weeks to the infant between 0 and 6 months of age an infant formula composition, comprising: (a) about 40 (25) to about 60 wt. % of a milk-derived fermented ingredient based on dry weight of the composition; (b) about 0.4 to about 1.5 wt. % galacto-oligosaccharides and fructo-oligosaccharides based on 100 ml of the composition; and (c) about 0.3 to about 0.7 wt. % of the sum of lactate and lactic acid based on dry weight of the composition, wherein the sum of L-lactic acid and L-lactate is more than 95 wt. % based on the sum of total lactic acid and lactate; and wherein the milk-derived fermented ingredient is fermented by Streptococcus hermophilus and/or Bifidobacterium breve.
Conclusion
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/VERA STULII/Primary Examiner, Art Unit 1791
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