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
The amendment to the claims filed after non-final office action on October 14, 2025 is acknowledged. Claims 7, 38, 40-41, 43 were amended, claims 5, 10-11, 13-14, 16-17, 19-21, 27, 29, 33-35, 42 were canceled, claim 44 was newly added and claims 1-9, 12, 15, 18, 22-26, 28, 30-32, 36-41, 43-44 are pending in the instant application. The restriction was deemed proper and made final previous office action.
The was restriction deemed proper and made FINAL in the previous office action. Claims 1-4, 6, 9, 12, 18, 22-26, 28, 30-32 are withdrawn as being drawn to a non-elected species/invention. Claims 7-8, 15, 36-41, 43-44 are examined on the merits of this office action.
*Please note that an additional Non Final follows because a prior office action withdrew a nonstatutory double patenting rejection based on the assumption that the filed terminal disclaimer had been approved. Upon further review, the terminal disclaimer was no approved. Accordingly, the double patenting rejection is reinstated and set forth below.
Withdrawn Rejections/Objections
The rejection of claims 7-8, 15, 36-41, 43 under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement (new matter) is withdrawn in view of amendment of the claims filed October 14, 2025.
The rejection of Claims 7-8, 15, 36-41, 43 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed October 14, 2025.
.
The rejection of claim(s) 7-8, 15, 36-41 and 43-44 under 35 U.S.C. 103 as being unpatentable over Yanhong (CN104430899 A1,cited in Applicant’s IDS) as evidenced by Layman (Nutrition Reviews, 2018, cited in Applicant’s IDS) in view of Jun (CN102524422 B, cited in Applicant’s IDS) as evidenced Whey Protein 101 (accessed on 1/19/2023, cited previously) in view of GNPD (cited in Applicant’s IDS 12/26/2023) in view of Drummond (“Drummond food Science Advisory, 2016, GRAS notice) is withdrawn in view of amendment of the claims filed October 14, 2025.
The rejection of Claims 7, 38, 40, 43 under 35 U.S.C. 103 as being unpatentable over GNPD (cited in Applicant’s IDS 12/26/2023) in view of Jun (CN102524422 B, cited in Applicant’s IDS), Campbell ( Reconstituting Powdered Infant Formula – A Review, pages 1-37, 2015) and Drummond (“Drummond food Science Advisory, 2016, GRAS notice) is withdrawn in view of amendment of the claims filed October 14, 2025.
The rejection of Claims 7-8, 15, 36-41, 43 under 35 U.S.C. 103 as being unpatentable over GNPD (cited in Applicant’s IDS 12/26/2023) in view of Jun (CN102524422 B, cited in Applicant’s IDS) and Campbell ( Reconstituting Powdered Infant Formula – A Review, pages 1-37, 2015) and Drummond (“Drummond food Science Advisory, 2016, GRAS notice) as applied to claims 7, 38, 40, 43 above in further view of Yanhong (CN104430899 A1,cited in Applicant’s IDS) is withdrawn in view of amendment of the claims filed October 14, 2025.
New Rejections
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.
Claim(s) 7-8, 15, 36-41 and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Yanhong (CN104430899 A1,cited in Applicant’s IDS) as evidenced by Layman (Nutrition Reviews, 2018, cited in Applicant’s IDS) in view of Jun (CN102524422 B, cited in Applicant’s IDS) as evidenced Whey Protein 101 (accessed on 1/19/2023, cited previously) in view of GNPD (cited in Applicant’s IDS 12/26/2023, “Five secret step 1 Baby Formula”), Drummond (“Drummond food Science Advisory, 2016, GRAS notice) and Okonogi (US4791193 A).
*Please note that claim 7 was amended to remove “free” and thus, claim interpretation has been amended as follows. Claim interpretation of amended claim 7: Claim 7 claims “A dry-blend powder formulation for oral administration comprising a protein component, wherein the protein component comprises dry particles of: (a) whey protein hydrolysate; (b) alpha-lactalbumin; (c) purified lactoferrin and (d) a milk component comprising milk protein naturally occurring in cow’s milk, wherein the purified lactoferrin dry particles comprise a purity of greater than 90% and are obtained from raw milk material using a weakly acidic cationic exchanger.
Regarding dry blend, Applicant’s specification states “In some embodiments, generally, essential nutrients and other components may be compounded in a wet process and then spray dried, after which certain heat-sensitive ingredients such as vitamins and lactoferrin may be dry-blended into the spray-dried powder” (see paragraph 0235, PGPUB). Thus, the formulation can be wet blended, then spray dried, and then dried purified lactoferrin can be added to the formulation and meet the limitations of “A dry blend powder”.
Regarding claims 7-8, Yanhong teaches an infant formula comprising raw milk at 57-62% of the formulation (which milk is 3.3% protein thus the raw milk protein would be 2.046 % of the formulation); hydrolyzed whey at 1.7-1.87% of the formulation and 1.6% to 2.2% of alpha-lactalbumin in the formulation. Yanhong teaches wherein the hydrolyzed protein is hydrolyzed whey Lacprodan 3071 (see claim 2). Yanyong teaches that the raw milk is Cow’s milk and whole milk (see bottom of page 7 of translation). As evidenced by Layman, lactoferrin is present in Cows and Human milk (see page 445, left hand column) at approximately 0.375% of total protein in Cow’s milk and would be approximately .0076% of the formulation of Yanhong. If one assumes 62% of the formulation was milk based on the claim (the raw milk protein would be 2.046 % of the formulation), alpha-lactalbumin would be 1.6-2.2% and WPH would be 1.7-1.87%. The total percentage of the formulation with WPH, alpha-lactalbumin and lactoferrin would be 5.35 and WPH would be 32% of the protein and lactalbumin would be about 29.9% of the protein. Thus, the WPH and lactalbumin falls within 15-63% (instant claim 39).
Regarding claim 8, the ratio of WPH to lactalbumin is 1:1. Yanhong teaches wet blending and then spraying to form a dried powder (which would be dry particles) (See comparative Example 3).
Yanhong is silent to the specific ratios of whey to alpha-lactalbumin (albeit 1:1 ratio is very close to 1.2/1 (5:4)) (claim 15); dry blending 90% or greater purity lactoferrin (with an iron saturation of less than equal 10.3%) with the other dry ingredients and the percentages found in instant claims 36-38, 40-41 and mixture of iron free/iron saturated lactoferrin (instant claim 43).
However, Jun discloses an infant formula milk powder comprising the digestion aiding protein alpha-lactalbumin (referred to as ALA throughout Jun) and the immunoprotective protein lactoferrin (see claim 1). Jun teaches various infant formulations comprising different acceptable amounts of ALA and lactoferrin (see Embodiments 1-10). Jun teaches combining different components (exclusive to lactoferrin) spray drying and then combining dried free lactoferrin with the dried other ingredients thus meeting the limitations of dry blending the particles of the composition (see page 3 of translation, “A method for preparing infant formula milk powder containing α-lactalbumin and lactoferrin composition, that is, a process combining wet process and dry process, the steps are as follows…”, see also page 5, lines 10-16).
Example 5 of Jun discloses a composition comprising 2.16 grams of alpha-lactalbumin, 0.18 grams of lactoferrin (a ratio of 12:1 and a total amount of 2.34 grams); 13 grams of skim milk powder (which is 0.4244 grams of protein given there are 8 grams of protein per 1 cup (245 grams) of skimmed milk); 10 grams of whey powder (of which whey powder is approximately 70-90% protein as evidenced by “Whey protein 101”, see attached handout, page 3, and thus 70% would have 7 grams of protein); 5 grams of whey protein thus resulting in a total protein amount of 14.7644 grams of protein. The percent amount of alpha lactalbumin protein in the protein component of the formulation would be 2.16/14.7644 which is 14.6% which is lower than the amount of Yanhong and would cause the percent of WPH and lactalbumin to over all be lower. The combined amount of lactalbumin and lactoferrin would be 2.34/14.7644 which is 15.8% of the protein component.
GNPD additionally teaches a powder infant formula comprising whey hydrolysate, alpha lactalbumin (287 mg), milk protein powder and lactoferrin (7 mg). The percent amount of the protein of alpha lactalbumin and lactoferrin is 17.2%.
Jun additionally teaches “The infant formula milk powder contains a specific amount of alpha-lactalbumin and lactoferrin and is close to breast milk. One small step is made in the progress of breast milk conversion of the infant formula milk powder.” Jun further teaches by supplementing with immune supporting proteins which are close to the breast milk, this will improve immunity of infants (see abstract). Thus, the goal of Jun was to create a formula that it is immune supporting and more closely mimicking of breast milk.
Drummond teaches of milk derived bovine lactoferrin for use in formulas including infant formulas (see Tables 2-5). Drummond teaches wherein the lactoferrin is greater than or equal to 95% purity (see page 34, tables 2-5) and wherein part of the lactoferrin is iron saturated and some not iron saturated (see Table 2, page 34, also Table 2-3, both iron saturated and not saturated forms present). Drummond teaches that the Bovine milk derived lactoferrin is considered to be safe for the intended use of infant formula (see page 13). Regarding claims 43-44, Drummond teaches various formulations comprising lactoferrin at high purity (99%) and with low iron saturation (5.9%) and also no iron content/saturation (see Table 2-8 and also Table 2-6). Such mixtures inherently reflect the presence of both iron bound and iron unbound (Free) lactoferrin molecules. Drummond additionally teaches that the lactoferrin is obtained from milk filtrate being passed over an ion exchange column containing Sepharose (see page 26 and also page 27, “Materials and processing Aids”, Also Table 2-4).
Okonogi teaches methods of purifying bovine lactoferrin from raw milk using weakly acidic cationic exchanger (see abstract).
It would have been obvious before the effective filing date of the claimed invention to dry blend in purified lactoferrin with high purity (95%, less contamination) into the formulation of Yanhong as taught by Jun, GNPD and Drummond. One of ordinary skill in the art would have been motivated to do so to mimic breast milk, provide immune supporting proteins such as lactoferrin (which is safe and pure as taught by Drummond) with the expectation of improving immunity or to provide immune support (see abstract). There is a reasonable expectation of success given that purified lactoferrin (in combination with WPH and alpha lactalbumin) in infant formula is beneficial in being immune supporting, more closely mimics breast milk and safe for use.
Additionally, one of ordinary skill in the art would have been motivated to use higher purity lactoferrin in infant formula given higher purity lactoferrin inherently contains fewer non lactoferrin milk components and residual impurities, which is a routine and expected outcome of purification. The use of higher purity lactoferrin therefore represents a conventional optimization to ensure consistent composition and quality of a known ingredient in infant nutritional products, with a reasonable expectation of success.
Furthermore, the amount of Whey protein, lactoferrin and alpha-lactalbumin are considered result effective variables and one of ordinary skill in the art would have optimized the amount of both components in the formula (within the amounts taught by Yanhong, Jun, GNPD and Drummond) to most closely mimic breast milk and to provide optimal immune support and nutrition to the infant (see MPEP 2144.05 (A)). Furthermore, MPEP 2144.05 states “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding the amount of hydrolysate and alpha-lactalbumin, GNPD teaches 16.8% for alpha lactalbumin and Yanhong teaches 32% WPH which would result in 48% which falls within the range of instant claims 36-37 and 39.
Regarding claims 38 and 40, GNPD additionally teaches a powder infant formula comprising whey hydrolysate, alpha lactalbumin (287 mg), milk protein powder and lactoferrin (7 mg) and the percent amount of the protein (total protein 1.7 grams) of alpha lactalbumin and lactoferrin is 17.2%.
Regarding claim 41, whey protein hydrolysate at 32% + 17.2% (alpha lactalbumin and lactoferrin) results in 49.2 which falls within the range of instant claim 41.
Regarding the newly added limitation of “obtained from raw milk material using a weakly acidic cation exchange process” in instant claim 7, this additional product by process limitation does not distinguish the claimed product from the prior art. As set out in Drummond, bovine lactoferrin is isolated from raw milk and skim milk using ion exchange chromatography, specifically using Sepharose Big Beads as the ion exchange resin (see Drummond, Table 2-4 and manufacturing description). The bound lactoferrin is eluted with sodium chloride, desalted by ultrafiltration, and spray dried to form purified lactoferrin dry particles.
Under product-by-process claim interpretation (see MPEP 2113), patentability is based on the product itself, not the recited process steps. Here, the prior art product is the same or indistinguishable from the claimed product, the product by process limitation does not impart patentable distinction even if the process were different.
Nevertheless, Okonogi teaches methods of purifying bovine lactoferrin from raw milk using weakly acidic cationic exchanger (see abstract).
It would have been obvious to a person of ordinary skill in the art to purify bovine lactoferrin using a weakly acidic cation-exchange process because Okonogi expressly teaches this purification method for bovine lactoferrin from raw milk. Applying Okonogi’s known purification technique to the lactoferrin Yanhong in view of Jun, GNPD, Drummond constitutes a routine substitution of equivalent purification methods that does not impart patentable distinction to the resulting product under product-by-process principles (MPEP § 2113).
Regarding claim 44, the applied prior art (Yanghong in view of Jun, GNPD, Drummond) teaches each of the recite features including a dry blend formulation for oral administration comprising the dry particles of WPH, alpha lactalbumin, purified lactoferrin obtained from raw milk, the lactoferrin purity, the iron saturation and a milk component.
Furthermore, iron saturation is a result effective variable in a lactoferrin preparation and routine optimization of iron saturation within known ranges would have been obvious to one of ordinary skill in the art (see MPEP 2144.05 II).
Response to Applicant’s Arguments
Applicant argues that the prior art combination fails to teach or suggest all the claim limitations. Newly added claim 44 comprises the same components and specifies that the purified lactoferrin dry particles comprise a purity > 90% and an iron saturation of < 10.3%, which matches the specifications of Bioferrin® 1000 as evidenced by Exhibit 3.
As noted throughout the NFOA, none of the prior art references (including Yanhong) disclose the combination of whey protein hydrolysate, alpha-lactalbumin, milk protein, and purified lactoferrin. The Office's assertion that Yanhong and GNPD teach all three components is completely unsubstantiated in the record; there simply is no reference that comprises all three components. If the Office's statement were true, then either Yanhong or GNPD would anticipate the claimed invention and the Office has not made such an assertion. For example, Yanhong makes no mention of using isolated lactoferrin at all, let alone a purified form of lactoferrin.
GNPD does not teach or suggest isolating or purifying lactoferrin at all, only lactoferrin from a list of "Nutrition Facts." In fact, the lactoferrin referred to in GNPD is more likely naturally found in the composition of "A2 milk" that is used in the infant formula rather than isolated/purified lactoferrin (GNPD, Product Description ("This baby formula contains A2 milk...")). The Office evens relies on the fact lactoferrin occurs in milk when it cites Yanhong as set forth, supra.
Therefore, none of the references anticipate the claimed combination. The Office alleges obviousness by piece-meal combining components from different references to arrive at the claimed infant formula. However, none of the references teach or suggest using purified lactoferrin in combination with WPH, alpha-lactalbumin, and milk protein as recited in the claims.
The only reference that specifies a purified lactoferrin product is Drummond (Table 2-5). However, Drummond makes no mention of or provides a reason for combining purified lactoferrin with other recited components to arrive at the claimed infant formula. In fact, the Office has not provided any reason why a person of ordinary skill in the art would go through the added expense of purifying lactoferrin and specifically using Drummond's lactoferrin to substitute or combine with the lactoferrin present in Yanhong or GNPD. The Office alleges that one of ordinary skill in the art "would have been motivated to do so to mimic breast milk, provide immune supporting proteins such as lactoferrin." However, there is no evidence to show that purified bovine lactoferrin with over 90% purity "mimics" breast milk; there simply is no evidence in the record that shows that highly pure lactoferrin as recited in the claims more closely mimics breast milk. This is not common knowledge and there is no literature that supports this assertion; in fact, as discussed below, iron saturation in lactoferrin does not mimic native lactoferrin present in milk when purified under acidic conditions. Since the Office's allegations that lactoferrin's increased safety by purification and mimicking human breast milk are essentially Official Notice, Applicant hereby traverses; the Office is required to provide documentary evidence to support their assertion in accordance with 37 CFR 1.104(d)(2). See MPEP § 2144.03(C) ("If applicant adequately traverses the examiner's assertion of official notice, the examiner must provide documentary evidence in the next Office action if the rejection is to be maintained. If the examiner is relying on personal knowledge to support the finding of what is known in the art, the examiner must provide an affidavit or declaration setting forth specific factual statements and explanation to support the finding.")
Even assuming, arguendo, the Office has a valid rationale for combining the references by using purified lactoferrin as taught by Drummond, none of the prior art references teach or suggest obtaining purified lactoferrin from raw milk material using a weakly acidic cationic exchanger.
As noted at paragraph [0139] of the originally filed specification, the purification process obtains "lactoferrin from raw milk material using a weakly acidic cationic exchanger, a washing step to remove nonabsorbed substances, and a desorbing step to obtain purified lactoferrin." As explained below, this process results in less iron saturation than naturally isolated lactoferrin.
Exhibit 1 evidences that iron atoms bound to lactoferrin are "removed under acidic conditions."2 For example, at weakly acidic pH 5.0, about 75% of bound iron is retained. Id. Thus, using a cationic exchanger under weakly acidic conditions results in less iron content bound to the lactoferrin than naturally isolated lactoferrin.
The '193 Patent (which is incorporated by reference), explains the use of weakly acidic conditions for the cation-exchanger of the present invention to achieve greater than 90% purity (col 5, lines 39-66) under weakly acidic conditions; these weakly acidic conditions have pH range of between 4.6 to 6.7 (see, e.g., col 3, lines 42-55; Table 1; and Examples 1-10 of the '193 Patent). As evidenced above, these conditions lead to purified lactoferrin that have less iron saturation.
The only reference that discusses lactoferrin purity is Drummond. Although Drummond references a lactoferrin purity of greater than 95% of protein, Drummond does not mention that purified lactoferrin is safer than lesser purified forms of isolated lactoferrin or that it "mimics" breast milk. Drummond only mentions that bovine lactoferrin safe to consume for infants (Drummond, pages 13-14) and that could apply to non-purified bovine lactoferrin as well. Therefore, the Office has not presented any reason why one of ordinary skill in the art would specifically use a purified form of lactoferrin over lactoferrin present in other cited prior art formulations. Given the added time and expense of purifying lactoferrin, there is no justification provided by the Office to use purified lactoferrin over existing lactoferrin found in milk or isolated in some other manner.
Drummond does not obtain lactoferrin using a weakly acidic cationic exchanger from raw milk such as discussed at paragraph [0139] of the instant application and throughout the '193 Patent that is made part of the instant application. Instead, Drummond only references a high performance liquid chromatograph ("HPLC method") to purify Lactoferrin. See Table 2-5. Even assuming, arguendo, that the purification method of Drummond uses a cation exchange column to obtain lactoferrin from raw milk, Drummond makes no reference of a weakly acidic cationic exchanger. Since the amount of iron bound is dependent on pH, using weakly acidic cationic exchangers result in structurally unique purified lactoferrin having a different degree of iron saturation than other cationic exchangers.
Moreover, the differences in lactoferrin iron saturation can actually be quantified based on the purified Bioferrin® lactoferrin products disclosed throughout the application. For example, in embodiments of the invention, the purified lactoferrin is Bioferrin® 2000 or Bioferrin® 1000 (paragraph [0238] of the originally filed specification). The only difference between Bioferrin® 2000 and Bioferrin® 1000 is the iron saturation.3 Exhibit 3 evidences that Bioferrin® 1000 has a lactoferrin purity of ">90%" and an iron saturation of less than equal to 10.3%. In contrast, the iron saturationof Drummond is "< 20%," which is nearly the double the maximum amount of iron saturation (Drummond, page 15, last paragraph and Table 2-5).
As evidenced above, even if the prior art is combined as applied by the Office, the purified lactoferrin based on the prior art combination is structurally different since Drummond's purified lactoferrin has a different iron saturation. Consequently, the resulting composition would still be structurally distinguished from what is claimed. Therefore, the claims are nonobvious because all the claim features are not taught or suggested by the prior art.
Applicant’s arguments have been fully considered but not found persuasive. Applicant argues that none of the cited references teach the combination of whey protein hydrolysate, alpha lactalbumin, milk protein and purified lactoferrin, and that the office has relied on impermissible hindsight by piecemeal combination. This argument is not found persuasive. The rejection is based on obviousness under 35 U.S.C 103, not anticipation. A proper obviousness rejection does not require a single reference to expressly teach all claimed elements as found in the claims. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Rather, the applied references collectively teach infant formula compositions comprising whey protein hydrolysate, alpha lactalbumin, and milk proteins (Yanhong, GNPD), while Drummond teaches purified bovine lactoferrin suitable for infant consumption. The combination merely substitutes a known lactoferrin ingredient taught by Drummond into the known infant formula compositions of Yanhong and GNPD to achieve predictable results.
Applicant argues that Yanhong and GNPD do not disclose isolated or purified lactoferrin, and instead merely reference lactoferrin naturally present in milk. This argument is not persuasive. The office action does not rely on Yanhong or GNPD to teach purification of lactoferrin. Rather, Drummond expressly teaches purified bovine lactoferrin products suitable for infant consumption, including lactoferrin with purity greater than 95% protein (Drummond, Tables 2-5, pages 13-15). The rejection relies on Drummond for highly purified lactoferrin, and on Yanhong and GNPD for the infant formula composition into which the highly purified lactoferrin is incorporated or utilized. Importantly neither reference teach away or exclude using highly purified lactoferrin in the formulations. Furthermore, the Examiner respectively disagrees that the Lactoferrin taught by GNPD is most likely not purified and is part of the A2 milk present. GNPD expressly lists “lactoferrin concentrates” as a discrete ingredient in the infant formula composition. A “lactoferrin concentrate” would have been understood by a person of ordinary skill in the art to be an isolated and enriched lactoferrin material, not merely native lactoferrin inherently present in milk. Thus, GNPD teaches the inclusion of a processed, concentrated lactoferrin component added to the formulation, rather than reliance on endogenous lactoferrin present in milk.
Applicant argues that the office has failed to provide a motivation to use the highly purified lactoferrin (greater than 90%), asserting that the office relied on Official notice and that there is no evidence that high purity lactoferrin mimics breast milk. This argument is not persuasive. The Office does not rely on Official Notice for the motivation to use the purified lactoferrin. The motivation is supported by Drummond, which teaches that purified bovine lactoferrin is safe for infant consumption, suitable for use in infant formulas, and manufactured to controlled purity and composition specifications. Drummond further teaches that higher (greater than 90%) purified lactoferrin is used in infant nutritional products to provide know lactoferrin benefits. One of ordinary skill in the art would have been motivated to incorporate the purified lactoferrin into know infant formula compositions to ensure consistent composition and reduce contaminants and provide a controlled and reproducible lactoferrin source for infant nutrition. These motivations are grounded in the teachings of Drummond and the well-recognized goals of infant formula composition, not Official Notice. Moreover, the rejection does not require a finding that purified lactoferrin “perfectly mimic breast milk”. Rather, it is sufficient that purified lactoferrin is known, safe and a suitable source of lactoferrin for infant formula making it obvious.
Applicant argues that Drummonds purified lactoferrin has a different iron saturation than claimed, and therefore the resulting composition would be structurally different. This argument is not persuasive.
Drummond teaches of milk derived bovine lactoferrin for use in formulas including infant formulas (see Tables 2-5). Drummond teaches wherein the lactoferrin is greater than or equal to 95% purity (see page 34, tables 2-5) and wherein part of the lactoferrin is iron saturated and some not iron saturated (see Table 2, page 34, also Table 2-3, both iron saturated and not saturated forms present). Drummond teaches that the Bovine milk derived lactoferrin is considered to be safe for the intended use of infant formula (see page 13). Regarding claims 43-44, Drummond teaches various formulations comprising lactoferrin at high purity (99%) and with low iron saturation (5.9%) and also no iron content/saturation (see Table 2-8 and also Table 2-6). Furthermore, iron saturation is a result effective variable in lactoferrin preparation and routine optimization of iron saturation within known ranges would have been obvious to one of ordinary skill in the art. Applicant has not provided evidence of unexpected results for the claimed iron saturation range sufficient to rebut the prima facie case. Nevertheless, Drummond specifically teaches lactoferrin with the percentage saturation claimed (less than 10.3%, instant claim 44),
Applicant argues Drummond does not use weakly acidic cationic exchanger and therefore cannot product the claimed lactoferrin. This argument is not persuasive. The claims are product claims, not method claims. For product by process limitations, patentability is based on the product itself, not the particular process by which it is made (see MPEP 2113). Drummond discloses purified lactoferrin having the claimed purity and iron saturation characteristics, regardless of the specific purification technique used. Applicant has not demonstrated that the claimed product is structurally distinct from Drummonds purified lactoferrin. Drummond already teaches partial/reduced iron saturation which fall within the claimed amount (claim 44) of less than 10.3%. Applicants have not demonstrated that the claimed purification process necessarily results in a lactoferrin product that is structurally distinct from the purified lactoferrin disclosed in the prior art.
Applicant argues “A person of ordinary skill in the art would have been led away from the claimed combination because the claimed purified lactoferrin has less iron saturation, which
is less resistant to thermal denaturation and proteolysis. Here, Exhibit 4 evidences that native isolated bovine lactoferrin has approximately 15- 20% of iron saturation. Thus, native bovine lactoferrin iron saturation is about the same as the iron saturation of lactoferrin of Drummond, which is
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20%. (Drummond, Table 2-5). In contrast, as evidenced above, the purified lactoferrin of the claimed infant formula is more apo-lactoferrin ("apo-Lf') (i.e., less iron saturated) than naturally isolated lactoferrin, which is more holo- lactoferrin ("holo-Lf') due to the weakly acidic conditions for the cationic exchanger used during purification. For example, as noted above, Bioferrin® 1000 has an iron saturation that is < 10.3%. Exhibit 2 evidences that the binding of iron by lactoferrin results in a change in its molecular conformation.6 In particular, when iron ions enter into the open interdomain cleft in each lobe of the lactoferrin, "the domains close over the iron atom resulting in a more compact structure. Thus, holo-Lf being more compact than the apo-Lf, is more resistant to thermal denaturation and proteolysis."7 Accordingly, it was well known prior to the effective filing date of the claimed invention that holo-Lf is more a person of ordinary skill in the art would want to use lactoferrin with more iron saturation (i.e., holo-Lf) rather than the purified lactoferrin of the present invention that has less iron saturation. Given that holo-Lf is more resistant to thermal denaturation and proteolysis, a person of ordinary skill in the art would therefore have been led away from using a highly purified lactoferrin obtained using a weakly acidic cationic exchanger that is more apo-Lf than native bovine lactoferrin with a higher iron saturation because it is not as susceptible to thermal denaturation and proteolysis. Proceeding to use a purified bovine lactoferrin that is more apo-Lf would be contrary to the accepted wisdom to use lactoferrin with higher iron saturation such as native isolated bovine lactoferrin or the purified lactoferrin as taught by Drummond that is more holo-Lf because holo- Lf is more stable. The fact that the claimed invention proceeds with using a less stable form lactoferrin is further evidence of nonobviousness.
Applicants arguments have been fully considered but not found persuasive. Applicant argues that a person of ordinary skill in the art would have been led away from the claimed composition because the purified lactoferrin has reduced iron saturation is allegedly less resistant to thermal denaturation and proteolysis. This argument is not found persuasive. As show in Drummond, the bovine milk derived lactoferrin product inherently comprises iron saturation values at or below those recited in the claims. Specifically, Drummonds batch data (Tables 2-7 and 2-8) demonstrate iron saturation values approximately 11% with multiple commercial batches exhibiting iron saturation below 10.3%, which overlaps with the clamed limitation. Thus, the claimed iron saturation range is not outside nor contrary to the properties of the lactoferrin taught by Drummond. Further, although Applicant asserts that lower iron saturation (apo-lactoferrin) is less stable than holo-lactoferrin, Drummond nevertheless expressly teaches the suitability and safety of this lactoferrin for infant formula, including processing steps such as pasteurization and spray drying. Accordingly, Drummond does not teach away. MPEP states “"the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…."(see MPEP 2143.01, I). Drummond does not criticize, discredit, or discourage the use of lactoferrin having reduced iron saturation, rather teaches the use of said products in infant formulas.
Applicant argues that “Unexpected results are commensurate in scope with the claimed invention because synergy occurs when the claimed components are combined, regardless of amount/concentration as demonstrated by the fact that synergism occurs across different protein levels. Here, as demonstrated above, the purified lactoferrin of the composition recited in the claims has a lower iron saturation than isolated/free lactoferrin of native bovine lactoferrin. Consequently, it would be expected to be less stable since it is less resistant to gastrointestinal digestion. However, the claimed combination surprisingly prevents this phenomenon from occurring based on the unexpected protective effect of the combination with WPH and alpha- lactalbumin. Applicant previously presented multiple Rule 132 Declarations based on the data in Rulan Jiang, et al., "Evaluation of Bioactivities of the Bovine Milk Lactoferrin-Osteopontin Complex in Infant Formulas," J. AGRIC. FOOD CHEM. 2020, 68, 6104-6111 (May 20, 2020), which is presented again here for the Office's convenience as Exhibit 5. In particular, Applicant discovered synergism based on an improved bioactivity of lactoferrin that is potentiated by WPH and alpha-lactalbumin that protect lactoferrin from digestion, resulting in significant improvement in the gut of infants when the protein components WPH, alpha-lactalbumin, and lactoferrin are combined and at different protein levels. See Declarations of Drs. Devon Kuehn and Bo Lonnerdal filed on 21 March 2021 (of record in the parent application in U.S. Patent No. 11,197,917). Thus, synergy based on the claimed combination occurs across different protein levels, which means synergy occurs regardless of concentration. As a result, the claims are commensurate in scope with the data presented because synergism is based on the inventive contribution of the combination of the claimed components themselves (i.e., the protective effect of WPH and alpha-lactalbumin) rather than a particular concentration range. The Office does not dispute the evidence of synergism but rather blatantly ignores this evidence. The Office has provided no basis to question Applicant's comparative data and assertion that the demonstrated results were unexpected. Since the Office has not provided any evidence to rebut Applicant's assertion of unexpected results, the Office "is constrained to accept [Applicant's] statement at face value" and "find the claims allowable." MPEP § 707.07(f). Moreover, the Office's allegation that the evidence does "not provide amounts" of WPH, lactoferrin or alpha-lactalbumin is clearly not supported by the facts. First, independent claim 7 does not recite any specific amounts lactoferrin, WPH, and alpha-lactalbumin. Moreover, the data from Exhibit 5 shows various protein ratios across the lactoferrin, WPH, and alpha-lactalbumin combination recited in the claims that were subject to in vitro digestion. For example, Table 1 of Exhibit 5 (reproduced below) details the composition of three blends of lactoferrin, alpha- lactalbumin, and WPH across multiple protein ratios ("three formula protein blends [three mixtures of LF & OPN, WPH..., and a-LA...]") in units of g/L.8 (TABLE L composition of three blends). As can be seen in Table 1, the amounts of lactoferrin were modulated relative to constant amounts of alpha-lactalbumin and WPH to demonstrate that potentiation occurs across different protein levels. Id. The above concentration ratio variations demonstrate not only that the concentrations are present, but also that these ratios were varied to prove synergy was not limited to a particular concentration. To further illustrate this point, the evidence presented in Exhibit 5 explicitly mentions that "the protein level was not constant among all samples in the in vitro analysis..."9 and that "the three protein blends show the same trend for bioactivities.. In fact, the entire point of modifying the ratios is to show that protein levels are not what dictate synergy but rather it is the protective effect itself that is the determination of unexpected results. Thus, the data demonstrates that synergism is not limited to a particular concentration range, that synergism occurs across a range of protein levels, and that the claimed combination itself is what drives the significant improvement in purified lactoferrin stability. As another data point, FIG. 2 of the article clearly shows data comparing lactoferrin/LF&OPN alone versus the combination of WPH and alpha-lactalbumin ("Blends") demonstrated as dark regions on the Western blot demonstrating regions that were not digested (reproduced below): As explained in the Declaration of Dr. Kuehn (previously provided) the claimed combination of WPH, alpha- lactalbumin, and lactoferrin ("Blends") synergistically enhances lactoferrin based on a protective effect and this can be seen in FIG. 2: "An unexpected result of the study was that peptides and proteins in WPH and alpha-lactalbumin appear to protect lactoferrin from in vitro digestion, potentiating its bioactivity. This result follows from Figure 2 on page 6016 of the publication." (The declaration, paragraph 17). The Office does not dispute the above data or that there is a nexus between the combination of components and the resulting synergistic potentiating effect of the combination. Rather, the Office improperly disregards it because the Office is expecting unexpected results over a claimed range of the claimed composition. The Office's position is not grounded in law because Applicant need only present one common property of synergism for the protein combination: "Evidence that the compound or composition possesses superior and unexpected properties in one of a spectrum of common properties can be sufficient to rebut aprimafacie case of obviousness." MPEP § 2145 citing In re Chupp, 816 F.2d at 646 (emphasis added). As noted above, none of the prior art references disclose a combination of WPH, alpha- lactalbumin isolate, and purified lactoferrin in any amount. The Office has not presented any rebuttal evidence to support its allegation that a specific concentration of each of the purified lactoferrin, WPH, and alpha-lactalbumin is critical or necessary for producing synergism between the claimed three components. To the contrary, Applicant has provided evidence showing that synergism occurs across different protein levels including three protein blends with different protein ratios, which means that synergism is based on the structural protective effect of WPH and alpha-lactalbumin rather than a particular concentration of components. The specific concentrations for each recited component are not critical. Thus, for the evidence of synergism to be commensurate in scope with the claims, the claims need to recite a formulation comprising the three components: purified lactoferrin, WPH, and alpha-lactalbumin, which is clearly recited in the independent claim. Accordingly, the clamed technology is commensurate in scope with evidence of synergy.
Applicant’s arguments have been fully considered but not fond persuasive. Applicant relies on Jiang (2020) to argue that unexpected synergistic effects occur when lactoferrin is combined with whey protein hydrolysate and alpha lactalbumin, and that such effects are commensurate in scope of the claimed invention. This arguments is not found persuasive. Jiang demonstrates that bovine LF forms complexes with OPN and that such LF-OPN complexes, when present in a specific experimental protein matrix, exhibit increased resistance to in vitro digestion and enhanced bioactivities at defined LF:OPN molar ratios (3:1, 5:1 and 8:1). While Jiang further reports that WPH and alpha lactalbumin may contribute to protective effects in those experiments, Jian does not establish that the claimed combination produces unexpected results across the full scope of the claims. Specifically, Jiang evaluates defined protein ratios and controlled experimental conditions, not the broad unlimited compositions recited in the claims, which do not specify LF:OPN rations, protein ratios, digestion conditions or other formulation constraints/parameters. The data in Jiang show variable effects depending on protein ratio with different biological endpoints peaking at different LF:OPN ratios (e.g. Figures 3-6), demonstrating that the observed effects are concentration and ratio dependent, rather than inherent to the presence of the claimed components. Jiang attributes enhanced stability and bioactivity primarily to formation of LF-OPN complex, not as an unexpected property form the claimed combination. The presence of WPH and alpha lactalbumin is described as potentially contributing to protection or stabilization, but Jiang does not establish that these components act in a manner that produces a greater than additive effect relative to their known individual functions, as required to demonstrate synergism. Rather, the data are consistent with additive or predictable stabilization effects from known protein-protein interactions, in particular LF-OPN. Furthermore, the claims do not recite any compositional parameters required for synergism. Claim 7 does not specify protein rations, relative concentrations, digestion conditions, or structural requirements necessary to produce effects observed in Jiang.
Take together, the results are tied to specific structural and compositional parameters, not the claims as broadly drafted. Jiang does not compare the claimed composition against the closet prior art formulation relied upon by the office in a manner sufficient to establish a nexus between the alleged unexpected results and the full scope of the claims. Accordingly, while Jiang demonstrates that certain protein combinations may exhibit enhanced bioactivity under particular experimental conditions, Applicant has not shown that such results are unexpected across substantially all embodiments encompassed by the claims as required under MPEP 716.02 and 2145.
Applicants argue that “Additional experiments of in vitro digestion without osteopontin was conducted to test each claimed component alone and in combination to demonstrate that the results are commensurate in scope with the claimed combination and confirm the synergistic protective effect. During the interview, the examiner acknowledged that Applicant's data shows a protective effect against lactoferrin and osteopontin (Lf-OPN) degradation but expressed that there was no data of lactoferrin alone and in combination with WPH and alpha-lactalbumin in combination. While Applicant disagrees that osteopontin plays a role in the protective effect of WPH and alpha-lactalbumin, solely in an effort to advance prosecution, Applicant hereby provides additional evidence of synergy that addresses the Office's point of contention during the interview. In particular, the Office is respectfully directed to Exhibit 6, which tests in vitro digestion for each component alone (including lactoferrin) and in combination with WPH and alpha-lactalbumin." The lactoferrin ("Lf') used is Bioferrin® 1000.2 As evidenced above, this purified Lf has the same purity/iron saturation of the lactoferrin recited in the claims. See claims 7 and 44. Applicants present Table 1 from Jiang, 2024. Applicants conclude that as shown in figure 2D-F, both LF and alpha-Lac are more resistant to in vitro digestion when complex with each other or other proteins. Applicants also state that both LF and a-lac alone were partly resistant to in vitro GI digestion, but they were relatively protected from digestion when in protein blends (figure 3D-F). Moreover, as evidenced by Figures 2 D-F and 3 D-F of Exhibit 6, band 7 (i.e., blend 3 which corresponds with the claimed composition) had substantial improvement over bands 5 and 6 (i.c., blends 1 and 2) in terms of in vitro digestion when subjected to Native/SDS PAGE and when probed with anti-Lf and anti-α-Lac antibodies. Therefore, synergism was demonstrated by testing each component individually and in specific combinations and verify Applicant's assertion that synergism occurs when purified lactoferrin is combined with WPH and alpha-lactalbumin as recited in the claims resulting from the protective effect of the protein complex. Prior to the effective filing date of the claimed invention, the significant improvement in purified lactoferrin's resistance to gastrointestinal digestion based on the protective effect of WPH and alpha-lactalbumin was unknown, which the Office does not dispute. The substantially improved properties against digestion based on the claimed combination is "ipso facto unexpected" and "should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d at 751. In sum, the prior art combination does not teach or suggest all the claim limitations. A person of ordinary skill in the art would have been led away from combining purified lactoferrin with lower iron saturation as recited in the claims with Yanhong given the worse resistance to gastrointestinal digestion. Finally, the above evidence of unexpected results demonstrates synergy and is further evidence of nonobviousness of the claimed invention. For all these reasons, Applicant submits that the claims are nonobvious over the cited prior art.
Applicant’s arguments have been fully considered. Applicant argues that Exhibit 6 (Jiang et al. 2024) demonstrates synergistic and unexpected results commensurate in scope of claims 7 and 44 based on additional in vitro digestion experiments allegedly showing a protective effect when purified lactoferrin is combined with WPH and alpha lactalbumin. These arguments have been fully considered but not found persuasive. Exhibit 6 does not establish synergism. Applicant characterizes the observed protection against in vitro digestion as “synergistic”. However, synergism requires a showing that the combined effect is greater than the expected additive effect of the individual components (see MPEP 716.02). Exhibit 6 shows lactoferrin alone exhibits some resistance to digestion, alpha lactalbumin alone exhibits some resistance to digestion, protein blends exhibit increased resistance relative to individual proteins. However, Applicant does not provide evidence of a synergistic effect. Figure 3 of Exhibit provides qualitative SDS Page and immunoblot images suggesting that lactoferrin and alpha lactalbumin are more readily detect after in vitro digestion when present in protein blends then when tested individually. However, the figure does not include quantitative analysis, statistical analysis or comparative testing against conventional lactoferrin used in the prior art. Accordingly the data do not demonstrate a statistically significant or unexpected improvement attributable to the use of purified lactoferrin, nor do they establish synergistic effects beyond the known behavior of protein complexes due to inherent properties of the proteins.
Applicants assert that the evidence is commensurate in scope because claims 7 and 44 do not recite specific concentrations. This argument is not persuasive. Although the claims are broad and open ended, the experimental evidence in Exhibit 6 is narrow limited to specific protein ratios, specific digestion conditions specific bends, Blends 1-3, a particular purified lactoferrin preparation. The claims broadly encompass any composition comprising purified lactoferrin, WPH, milk component, and alpha lactalbumin without any limitation of ratio, concentration, digestion conditions or formulation context. Alleged unexpected results should be commensurate in scope (see MPEP 716.02(d)).
Applicants further emphasize that Exhibit 6 includes testing of individual components alone. However, testing components individually does not by itself establish unexpected results. The data show that each protein exhibits some digestion resistance and blends increased resistance.
Applicants cite In Re Soni (54 F.3d (Fed Cir 1995), arguing that improved properties are “ipso facto unexpected”. In Soni, the claimed invention exhibited a dramatic and quantitively unexpected improvement, clearly beyond what the prior art would predict. Applicants reliance on In Re Soni is not found persuasive. The evidence does not compare the claimed purified lactoferrin to the closest prior art lactoferrin compositions, nor does it isolate the alleged inventive feature (e.g. purification or iron saturation). Accordingly, the results are not “ipso facto unexpected” and do not demonstrate synergy or rebut the prima facie case of obviousness.
Applicants argue that a person of ordinary skill would have been led away from combining purified lactoferrin with lower iron saturation due to digestion concerns. This argument is not persuasive. The cited evidence does not demonstrate that the prior art discouraged such combinations. At most, it shows that iron saturation may influence stability, but does not teach away that blending with other milk proteins would be ineffective or undesirable.
Furthermore, the prior art already teaches the combination of Lactoferrin (purified in GNPD), alpha lactalbumin, WPH, Milk protein components together in infant formulas (see Yanhong and GNPD), so the combination is not new and known in the infant formula art. Therefore, the potentially distinguishing feature is the use of higher purified lactoferrin or higher purified lactoferrin with reduced iron saturation. Unexpected results must be shown by comparison with the closest prior art. There is no comparison shown between purified vs not purified lactoferrin or low iron vs. high iron etc… Applicants have not provided comparative data evaluating highly purified lactoferrin against non-purified or just purified lactoferrin in otherwise identical formulations. Therefore, the evidence is not commensurate in scope with the claims and does not establish unexpected results in view of the closest prior art.
Claims 7, 38, 40, 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over GNPD (cited in Applicant’s IDS 12/26/2023, “Five Secret Step 1 Baby Formula”) in view of Jun (CN102524422 B, cited in Applicant’s IDS), Campbell ( Reconstituting Powdered Infant Formula – A Review, pages 1-37, 2015, cited previously), Drummond (“Drummond food Science Advisory, 2016, GRAS notice) and Okonogi (US4791193 A).
GNPD teaches a dry powder infant formula for improved smooth digestion comprising whey protein hydrolysate, alpha lactalbumin (287 mg), milk protein powder with casein (which occurs in cow’s milk) and purified lactoferrin (7 mg) (see page 2, list of ingredients). The percent amount of the protein of alpha lactalbumin and lactoferrin is 17.2%.
GNPD is silent to (i) the formulation being a dry blend formulation even though it teaches the formulation being a powder and including powders for the different components (see ingredients) and (ii) purified lactoferrin dry particles with a purity of greater than 90%.
Jun discloses an infant formula milk powder comprising the digestion aiding protein alpha-lactalbumin (referred to as ALA throughout Jun) and the immunoprotective protein lactoferrin (see claim 1). Jun teaches various infant formulations comprising different acceptable amounts of ALA and lactoferrin (see Embodiments 1-10). Jun teaches combining different components (exclusive to lactoferrin) spray drying and then combining dried free lactoferrin with the dried other ingredients thus meeting the limitations of dry blending (see page 3 of translation, “A method for preparing infant formula milk powder containing α-lactalbumin and lactoferrin composition, that is, a process combining wet process and dry process, the steps are as follows…”, see also page 5, lines 10-16).
Campbell teaches that “There are benefits associated with all methods from a product quality point of view, i.e. dry blending allows some of the highly oxidative minerals to be added at the dry blend stage, potentially increasing the shelf life of the product and enhancing the flavor profile while at the same time giving economies of base powder manufacturing” (see page 12, second paragraph).
Drummond teaches of milk derived bovine lactoferrin for use in formulas including infant formulas (see Tables 2-5). Drummond teaches wherein the lactoferrin is greater than or equal to 95% purity (see page 34, tables 2-5) and wherein part of the lactoferrin is iron saturated and some not iron saturated (see Table 2, page 34, also Table 2-3, both iron saturated and not saturated forms present). Drummond teaches that the Bovine milk derived lactoferrin is considered to be safe for the intended use of infant formula (see page 13). Regarding claims 43-44, Drummond teaches various formulations comprising lactoferrin at high purity (99%) and with low iron saturation (5.9%) and also no iron content/saturation (see Table 2-8 and also Table 2-6). Such mixtures inherently reflect the presence of both iron bound and iron unbound (Free) lactoferrin molecules. Drummond additionally teaches that the lactoferrin is obtained from milk filtrate being passed over an ion exchange column containing Sepharose (see page 26 and also page 27, “Materials and processing Aids”, Also Table 2-4).
Okonogi teaches methods of purifying bovine lactoferrin from raw milk using weakly acidic cationic exchanger (see abstract).
It would have been obvious before the effective filing date of the claimed invention to dry blend the formulation (purified lactoferrin and in particular with high purity, greater than 90%) of GNPD. As taught by Jun, dry blending is a known and acceptable technique for preparing infant formula compositions comprising lactoferrin and alpha-lactalbumin. One of ordinary skill in the art would have been motivated to do so to increase the shelf life of the product due to preservation of more oxidative ingredients and given Jun teaches dry blending of the infant formulation. There is a reasonable expectation of success given both wet and dry blending are well known processes in the infant formula making art.
One of ordinary skill in the art would have been further motivated to use high purity lactoferrin (95%) in infant formulations to have less contamination. There is a reasonable expectation of success given that highly purified lactoferrin in infant formula is beneficial in being immune supporting and safe for use.
Additionally, one of ordinary skill in the art would have been motivated to use higher purity lactoferrin in infant formula given higher purity lactoferrin inherently contains fewer non lactoferrin milk components and residual impurities, which is a routine and expected outcome of purification. The use of higher purity lactoferrin therefore represents a conventional optimization to ensure consistent composition and quality of a known ingredient in infant nutritional products, with a reasonable expectation of success.
Regarding the newly added limitation of “obtained from raw milk material using a weakly acidic cation exchange process” in instant claim 7, this additional product by process limitation does not distinguish the claimed product from the prior art. As set out in Drummond, bovine lactoferrin is isolated from raw milk and skim milk using ion exchange chromatography, specifically using Sepharose Big Beads as the ion exchange resin (see Drummond, Table 2-4 and manufacturing description). The bound lactoferrin is eluted with sodium chloride, desalted by ultrafiltration, and spray dried to form purified lactoferrin dry particles.
Under product-by-process claim interpretation (see MPEP 2113), patentability is based on the product itself, not the recited process steps. Here, the prior art product is the same or indistinguishable from the claimed product, the product by process limitation does not impart patentable distinction even if the process were different.
Nevertheless, Okonogi teaches methods of purifying bovine lactoferrin from raw milk using weakly acidic cationic exchanger (see abstract).
It would have been obvious to a person of ordinary skill in the art to purify bovine lactoferrin using a weakly acidic cation-exchange process because Okonogi expressly teaches this purification method for bovine lactoferrin from raw milk. Applying Okonogi’s known purification technique to the lactoferrin of GNPD in view of Jun, Campbell and Drummond constitutes a routine substitution of equivalent purification methods that does not impart patentable distinction to the resulting product under product-by-process principles (MPEP § 2113).
Response to Applicant’s Arguments
Applicant argues that As evidenced by Exhibit 1 and as explained in the other cited prior art rejection above, Drummond's iron saturation differs from the lactoferrin recited in the claims. Drummond teaches a purified lactoferrin that is structurally distinct from the claimed combination because it is not purified using a weakly acidic cationic exchanger and, thus, has a different iron saturation than the claimed purified lactoferrin. Moreover, neither GNPD nor Campbell teach or suggest the use of purified lactoferrin at all. Therefore, even if the prior art is combined as applied by the Office, the purified lactoferrin based on the prior art combination is structurally different from the claimed lactoferrin recited in the instantly claimed infant formula. Therefore, the claims are nonobvious because all the claim features are not taught or suggested by the prior art. There is no evidence to show that purified bovine lactoferrin with over 90% purity "less contamination/higher safety" (NFOA, page 14). There simply is no evidence in the record that shows that highly pure lactoferrin as recited in the claims more closely mimics breast milk or has higher safety than native bovine lactoferrin. higher safety than native bovine lactoferrin. This is not common knowledge and there is no literature that supports this assertion; in fact, as discussed below, iron saturation in lactoferrin does not mimic native lactoferrin present in milk when purified under acidic conditions. Since the Office's allegations that lactoferrin's increased safety by purification and mimicking human breast milk are essentially Official Notice, Applicant hereby traverses; the Office is required to provide documentary evidence to support their assertion in accordance with 37 CFR 1.104(d)(2).
Applicants arguments have been fully considered but not found persuasive. First, Applicants reliance on differences in purification method and resulting iron saturation is not convincing. The claims recite a product, not a method, and under product by process principles, patentability is based on the product itself, not the process by which it is made. Drummond expressly teaches highly purified lactoferrin (greater than 95-99% purity) suitable for use in infant formula and discloses mixtures containing both iron bound and iron free forms of lactoferrin. Applicant has not established that the claimed lactoferrin is structurally or functionally distinct from the lactoferrin taught by Drummond in any way that would impart patentable distinction.
Second, Applicants assert that GNPD and Campbell do not teach “purified” lactoferrin. However, GNPD teaches infant formula compositions with lactoferrin in combination with alpha-lactalbumin and whey protein components. The Examiner respectively disagrees that the Lactoferrin taught by GNPD is most likely not purified and is part of the A2 milk present. GNPD expressly lists “lactoferrin concentrates” as a discrete ingredient in the infant formula composition. A “lactoferrin concentrate” would have been understood by a person of ordinary skill in the art to be an isolated and enriched lactoferrin material, not merely native lactoferrin inherently present in milk. Thus, GNPD teaches the inclusion of a processed, concentrated lactoferrin component added to the formulation, rather than reliance on endogenous lactoferrin present in milk.
Campbell teaches formulation techniques such as dry blending for infant formula powders. Drummond supplies the well-known source of purified bovine lactoferrin for infant nutrition. A person of ordinary skill in the art would have reasonably combined these teachings to arrive at the claimed composition with the higher purity lactoferrin (see rejection above). It is the combination of the references that render obvious the composition of the instant claims.
Third, Applicant’s argument that there is no evidence that lactoferrin having greater than 90% purify provides less contamination, higher safety or closer mimicry of human breast milk is not persuasive. The office has not relied on such assertions as a critical or required distinction for patentability. Moreover, Drummond teaches that highly purified bovine lactoferrin is suitable and safe for infect formula use, which reasonably supports its selection in infant nutritional formulations. Applicant has not provided evidence demonstrating that the claimed purity or iron saturation confers structural or functional difference over the prior art sufficient to overcome the rejection.
Applicant further argues that “Moreover, one of ordinary skill in the would have been led away from modifying GNPD's infant formula to add or substitute purified lactoferrin to arrive at the claimed invention because lactoferrin in milk has higher iron saturation than the claimed purified lactoferrin, which means the lactoferrin is less stable because it is less resistant to thermal denaturation and proteolysis as evidenced by Exhibit 2 and as discussed above. Finally, the instability of the purified lactoferrin recited in the claims is surprisingly and unexpectedly avoided based on the protective effect of the combination of alpha-lactalbumin and WPH as evidenced by Exhibits 5 and 6 and as discussed in the prior art rejection above over Yanhong.
Applicants arguments have been fully considered but not found persuasive. Applicants argument that a person of ordinary skill in the art would have been led away from adding or substituting purified lactoferrin into GNPD due to alleged instability associated with lower iron saturation is not persuasive. GNPD, Jun and Drummond each teach infant formula compositions that already include lactoferrin in combination with alpha-lactalbumin and whey derived proteins, demonstrating that inclusion of lactoferrin in such formulations was desirable and routine. GNPD specifically teaches use of lactoferrin concentrates. Applicant’s assertions that lower iron saturation necessarily renders the lactoferrin unsuitable for infant formula is not supported by the prior art of record and is contradicted by Drummond. Drummond teaches high purity lactoferrin compositions including low iron and partially iron free forms for use in infant formula. Moreover, a “led away” arguments requires a reference to criticize, discredit or discourage the claimed modification, which is not present in any of the references provided. At most, Applicant identifies a difference in iron saturation, which does not rise the level of a teaching away, especially since the prior art teaches the same components for the same purpose (see MPEP 2123 II). Accordingly, the asserted instability does not negate the motivation to combine or render the claimed invention non-obvious. Applicants reiterate the aforementioned unexpected results/synergistic effect arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference.
Claims 7-8, 15, 36-41, 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over GNPD (cited in Applicant’s IDS 12/26/2023, “Five secret step 1 Baby Formula”) in view of Jun (CN102524422 B, cited in Applicant’s IDS), Campbell ( Reconstituting Powdered Infant Formula – A Review, pages 1-37, 2015), Drummond (“Drummond food Science Advisory, 2016, GRAS notice) and Okonogi (US4791193 A) as applied to claims 7, 38, 40, 43-44 above in further view of Yanhong (CN104430899 A1,cited in Applicant’s IDS).
The teachings of GNPD, Jun, Campbell, Drummond and Okonogi are provided in the above rejection. The combined teachings are silent to the specific amount of whey protein hydrolysate.
However, Yanhong teaches an infant formula comprising raw milk at 57-62% of the formulation (which milk is 3.3% protein thus the raw milk protein would be 2.046 % of the formulation); hydrolyzed whey at 1.7-1.87% of the formulation and 1.6% to 2.2% of alpha-lactalbumin in the formulation. Yanhong teaches wherein the hydrolyzed protein is hydrolyzed whey Lacprodan 3071 (see claim 2). Yanyong teaches that the raw milk is Cow’s milk and whole milk (see bottom of page 7 of translation). If one assumes 62% of the formulation was milk based in the claim (the raw milk protein would be 2.046 % of the formulation), alpha-lactalbumin would be 1.6-2.2% and WPH would be 1.7-1.87%. The total percentage of the formulation with WPH, alpha-lactalbumin and lactoferrin would be 5.35 and WPH would be 32% of the protein; lactalbumin would be about 29.9% of the protein and lactoferrin would be .00776 % of the protein content. Thus, the WPH and lactalbumin falls within 15-63% of the final protein content in the formulation. Regarding claim 8, the ratio of WPH to lactalbumin is 1:1.
GNPD teaches a protein content of 1.7 grams and thus, based on the amounts taught by Yanhong, 32% of the protein content would be .544 grams of whey protein hydrolysate. GNPD teaches .287 grams of alpha lactalbumin and 7 mg of lactoferrin. This would result in a ratio of whey protein hydrolysate to alpha lactalbumin of 1.89/1 meeting the limitations of instant claims 8 and 15. Furthermore, regarding claims 36-37, 39, the combined amounts of WPH and alpha lactalbumin would be 48% (.544+.287/1.7 grams). Regarding claim 41, the combined WPH, alpha lactalbumin and free lactoferrin is 48%+17.2% thus meeting the limitations of instant claim 41.
The amount of Whey protein hydrolysate is considered a result effective variables and one of ordinary skill in the art would have optimized the amount of WPH (based on the teachings of Yanhong) in the formula to provide optimal nutrition to the infant (see MPEP 2144.05 (A)). Furthermore, MPEP 2144.05 states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to try the amounts of WPH taught by Yanhong. One of ordinary skill in the art would have been motivated to do so give the amount taught in Yanhong is for the same purpose, treating sensitive infants and use in infant formula for nutrition. There is a reasonable expectation of success given WPH is being taught for the same purpose, nutrition in sensitive infants.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference.
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 7-8, 15, 36-41, 43-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of co-pending Application No. 17548332 (reference application) in view of Jun and Drummond (see above references). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a dry blend powder formulation for oral administration comprising particles of purified lactoferrin (greater than 90%), alpha lactalbumin, whey protein hydrolysate and milk component (claim 7). The instant application further claims WPH/lactalbumin in a ratio of 4:1-1:1 (claim 8); 7:2-5:4 (claim 15); 15-53% bye weight WPH and alpha lactalbumin (claim 36); 15-49% WPH/alpha-lactalbumin (Claim 37); 15-30% lactalbumin/lactoferrin (Claim 38); 15-63% WPH/lactalbumin (Claim 39); 15-45% lactalbumin/lactoferrin); WPH, lactalbumin and lactoferrin 45-80% (claim 41); apo lactoferrin and hololactoferrin (claim 43); iron saturation of less than 10.3% of lactoferrin.
Co-pending Application 17/5483322 claims an oral formulation comprising alpha lactalbumin and lactoferrin (see claim 1) and amounts that overlap with the ratios found in the instant claims (see claim 1) and purified from lactoferrin from raw milk using weak cationic exchanger. Co-pending Application 17/5483322 further claims alpha-lactalbumin in a range of 14-20% of the protein component and 1-6% of lactoferrin which results in a total of 15-26%. Co-pending Application 17/5483322 claims a ratio of 3:1 to 7:1 WPH and lactoferrin (Claim 9); 2:1-4:1 alpha lactalbumin and lactoferrin (Claim 9) which overlap with the instant claims. Co-pending Application 17/5483322 claims purified lactoferrin (claim 15). Nevertheless, the ratios of lactoferrin and lactalbumin and the percent total of the protein component are considered result effective variables.
It would be obvious to one of ordinary skill in the art to optimize the amounts of each lactalbumin, and lactoferrin (all of which are result effective variables) in the infant formulations to most closely mimic human breast milk. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Therefore, it would have been obvious to optimize the amounts of each of alpha-lactalbumin, and lactoferrin to achieve optimal activity and therapeutic effectiveness of the infant formula in infants that most closely mimics breast milk. There is a motivation to optimize since it is normal desire of scientists or artisans to improve upon what is already generally known with a reasonable expectation that optimization would at least work the same.
Co-pending Application No. 17548332 is silent to purified lactoferrin greater than 90%, iron saturation (and lack thereof), and dry blend particles.
However, Jun discloses an infant formula milk powder comprising the digestion aiding protein alpha-lactalbumin (referred to as ALA throughout Jun) and the immunoprotective protein lactoferrin (see claim 1). Jun teaches various infant formulations comprising different acceptable amounts of ALA and lactoferrin (see Embodiments 1-10). Jun teaches combining different components (exclusive to lactoferrin) spray drying and then combining dried free lactoferrin with the dried other ingredients thus meeting the limitations of dry blending the particles of the composition (see page 3 of translation, “A method for preparing infant formula milk powder containing α-lactalbumin and lactoferrin composition, that is, a process combining wet process and dry process, the steps are as follows…”, see also page 5, lines 10-16).
Jun additionally teaches “The infant formula milk powder contains a specific amount of alpha-lactalbumin and lactoferrin and is close to breast milk. One small step is made in the progress of breast milk conversion of the infant formula milk powder.” Jun further teaches by supplementing with immune supporting proteins which are close to the breast milk, this will improve immunity of infants (see abstract). Thus, the goal of Jun was to create a formula that it is immune supporting and more closely mimicking of breast milk.
Drummond teaches of milk derived bovine lactoferrin for use in formulas including infant formulas (see Tables 2-5). Drummond teaches wherein the lactoferrin is greater than or equal to 95% purity (see page 34, tables 2-5) and wherein part of the lactoferrin is iron saturated and some not iron saturated (see Table 2, page 34, also Table 2-3, both iron saturated and not saturated forms present). Drummond teaches that the Bovine milk derived lactoferrin is considered to be safe for the intended use of infant formula (see page 13). Drummond teaches various formulations comprising lactoferrin at high purity (99%) and with low iron saturation (5.9%) and also no iron content/saturation (see Table 2-8 and also Table 2-6). Such mixtures inherently reflect the presence of both iron bound and iron unbound (Free) lactoferrin molecules. Drummond additionally teaches that the lactoferrin is obtained from milk filtrate being passed over an ion exchange column containing Sepharose (see page 26 and also page 27, “Materials and processing Aids”, Also Table 2-4).
It would have been obvious before the effective filing date of the claimed invention to dry blend in purified lactoferrin with high purity (95%, less contamination) into the formulation of Co-pending 17/548332 as taught by Jun and Drummond. One of ordinary skill in the art would have been motivated to do so to mimic breast milk, provide immune supporting proteins such as lactoferrin (which is safe and pure as taught by Drummond) with the expectation of improving immunity or to provide immune support (see abstract). There is a reasonable expectation of success given that purified lactoferrin (in combination with WPH and alpha lactalbumin) in infant formula is beneficial in being immune supporting, more closely mimics breast milk and safe for use.
Additionally, one of ordinary skill in the art would have been motivated to use higher purity lactoferrin in infant formula given higher purity lactoferrin inherently contains fewer non lactoferrin milk components and residual impurities, which is a routine and expected outcome of purification. The use of higher purity lactoferrin therefore represents a conventional optimization to ensure consistent composition and quality of a known ingredient in infant nutritional products, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7-8, 15, 36-41, 43-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent NO. 11197917 B2 (reference application) in view of Jun and Drummond (see above rejections). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a dry blend powder formulation for oral administration comprising particles of purified lactoferrin (greater than 90%), alpha lactalbumin, whey protein hydrolysate and milk component (claim 7). The instant application further claims WPH/lactalbumin in a ratio of 4:1-1:1 (claim 8); 7:2-5:4 (claim 15); 15-53% bye weight WPH and alpha lactalbumin (claim 36); 15-49% WPH/alpha-lactalbumin (Claim 37); 15-30% lactalbumin/lactoferrin (Claim 38); 15-63% WPH/lactalbumin (Claim 39); 15-45% lactalbumin/lactoferrin); WPH, lactalbumin and lactoferrin 45-80% (claim 41); apo lactoferrin and hololactoferrin (claim 43); iron saturation of less than 10.3% of lactoferrin.
US Patent No. 11197917 B2 claims an oral formulation comprising WPH, alpha lactalbumin and lactoferrin (claim 1). US Patent No. 11197917 B2 further claims amounts of lactoferrin at 1-6%, lactalbumin at 14-20% and WPH at 26-35% and a milk component (see claim 1). US Patent No. 11197917 B2 claims WPH lactoferrin ratios of 3:1-7:1 and lactalbumin/lactoferrin at ratios of 2:1-4:1 (see claim 4). The ratios of lactoferrin, WPH and lactalbumin and the percent total of the protein component are considered result effective variables.
It would be obvious to one of ordinary skill in the art to optimize the amounts of each lactalbumin, WPH, lactoferrin (all of which are result effective variables) in the infant formulations to most closely mimic human breast milk. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Therefore, it would have been obvious to optimize the amounts of each of alpha-lactalbumin, and lactoferrin to achieve optimal activity and therapeutic effectiveness of the infant formula in infants that most closely mimics breast milk. There is a motivation to optimize since it is normal desire of scientists or artisans to improve upon what is already generally known with a reasonable expectation that optimization would at least work the same.
US Patent No. ‘917 is silent to purified lactoferrin greater than 90%, iron saturation (and lack thereof), and dry blend particles.
However, Jun discloses an infant formula milk powder comprising the digestion aiding protein alpha-lactalbumin (referred to as ALA throughout Jun) and the immunoprotective protein lactoferrin (see claim 1). Jun teaches various infant formulations comprising different acceptable amounts of ALA and lactoferrin (see Embodiments 1-10). Jun teaches combining different components (exclusive to lactoferrin) spray drying and then combining dried free lactoferrin with the dried other ingredients thus meeting the limitations of dry blending the particles of the composition (see page 3 of translation, “A method for preparing infant formula milk powder containing α-lactalbumin and lactoferrin composition, that is, a process combining wet process and dry process, the steps are as follows…”, see also page 5, lines 10-16).
Jun additionally teaches “The infant formula milk powder contains a specific amount of alpha-lactalbumin and lactoferrin and is close to breast milk. One small step is made in the progress of breast milk conversion of the infant formula milk powder.” Jun further teaches by supplementing with immune supporting proteins which are close to the breast milk, this will improve immunity of infants (see abstract). Thus, the goal of Jun was to create a formula that it is immune supporting and more closely mimicking of breast milk.
Drummond teaches of milk derived bovine lactoferrin for use in formulas including infant formulas (see Tables 2-5). Drummond teaches wherein the lactoferrin is greater than or equal to 95% purity (see page 34, tables 2-5) and wherein part of the lactoferrin is iron saturated and some not iron saturated (see Table 2, page 34, also Table 2-3, both iron saturated and not saturated forms present). Drummond teaches that the Bovine milk derived lactoferrin is considered to be safe for the intended use of infant formula (see page 13). , Drummond teaches various formulations comprising lactoferrin at high purity (99%) and with low iron saturation (5.9%) and also no iron content/saturation (see Table 2-8 and also Table 2-6). Such mixtures inherently reflect the presence of both iron bound and iron unbound (Free) lactoferrin molecules. Drummond additionally teaches that the lactoferrin is obtained from milk filtrate being passed over an ion exchange column containing Sepharose (see page 26 and also page 27, “Materials and processing Aids”, Also Table 2-4).
It would have been obvious before the effective filing date of the claimed invention to dry blend in purified lactoferrin with high purity (95%, less contamination) into the formulation of US Patent NO. ‘917 as taught by Jun and Drummond. One of ordinary skill in the art would have been motivated to do so to mimic breast milk, provide immune supporting proteins such as lactoferrin (which is safe and pure as taught by Drummond) with the expectation of improving immunity or to provide immune support (see abstract). There is a reasonable expectation of success given that purified lactoferrin (in combination with WPH and alpha lactalbumin) in infant formula is beneficial in being immune supporting, more closely mimics breast milk and safe for use.
Additionally, one of ordinary skill in the art would have been motivated to use higher purity lactoferrin in infant formula given higher purity lactoferrin inherently contains fewer non lactoferrin milk components and residual impurities, which is a routine and expected outcome of purification. The use of higher purity lactoferrin therefore represents a conventional optimization to ensure consistent composition and quality of a known ingredient in infant nutritional products, with a reasonable expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/
Examiner, Art Unit 1654