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
2. Applicants’ arguments and amendments filed on 10/07/2026, overcomes the rejections of record. Upon review, examiner has made a new ground of rejection using Bottomley et al as primary prior art in order to strengthen the rejection. Therefore, the new grounds of rejection as set forth below are necessitated by applicants’ amendment and therefore, the following action is made as non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn
Status of the application
3. Claims 1-7, 10-17 are pending in this office action.
Claims 8, 9, 18 have been cancelled.
Claims 1-7, 10-17 have been rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 depends on cancelled claim 8. This makes claim 12 unclear and , therefore, indefinite. Cancelled claim 8 was dependent on independent claim 1. Therefore, claim 12 should ideally depend on claim 1. Applicants are advised to amend claim 12 to depend on claim 1 to overcome 112 second paragraph rejection.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. 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 non-obviousness.
9. Claim(s) 1-7, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bottomley et al. USPN 5194591 in view of Etzel et al. US 2014/ 0234506 in view of Heidebrecht et al. (J Chromatography Vol 1562, pages 59-68, 2018: Posted by the applicant dated 10/20/2023) and in view of Muronen et al. (WO2017103336A1·2017-06-22) and further in view of D1 et al. JP 2010524550 A (Inventor name not in English; hereinafter, D1 et al.).
10. Regarding claims 1, 2, 7, 13, 14, Bottomley et al. discloses a method to produce a liquid whey protein concentrate including whey from cheese processing (i.e. cheese whey) is subjected to ultrafiltration through a membrane having a preferred molecular weight cut-off of about 500 kDa directly produce an immunoglobulin enriched whey protein concentrate (at least in col 3 lines 3-5, col 4 lines 20-25, 30-35) in order to have an immunoglobulin enriched concentrate. It is known and Etzel et al. has also disclosed that MW of alpha lactalbumin is 14.2 kDa and beta lactalbumin is 18.3 kDa ([0029]). It is also taught by Bottomley et al. (col 4 lines 20-22, 26-30) that UF retentate (500 kDa MWCO) retains large immunoglobulin (col 4 lines 20-30) in the retentate.
Therefore, it would have been obvious that these proteins will pass through membrane when 500 kDa MWCO membrane is used.
In addition, it is also to be noted that the disclosed UF method with 500 kDa MWCO membrane meets identical claimed UF method with 500 kDa MWCO membrane and therefore, it would have the identical claimed property of obtaining permeate enriched in lactose, salts, alpha lactalbumin, beta lactalbumin and an UF retentate which retains large immunoglobulin.
It is evidenced by applicants’ specification and as claimed in claim 2 that “the casein reduced milk” is cheese whey MF separated casein and milk serum protein resulting native whey (in PGPUB [0024]). This meets claims 1, 2, 14.
It is also evidenced by Etzel et al. that casein-reduced swiss cheese whey may have pH 6.8, Swiss Cheese whey ([0051], [0052], [0086]) also (Etzel et al. [0051], [0052]).
Therefore, Bottomley et al. meets claim 1 (i).
Bottomley et al. meets claim 2 (e.g. cheese whey , at least col 5 example 3, first line and col 6 example 4, first two lines).
Bottomley et al. is silent about claim 1 (ii).
Bottomley et al. discloses that the method concentrates immunoglobulin enriched whey (at least in Bottomley et al. col 4 lines 29-30). However, in order to have purer immunoglobulin from enriched immunoglobulin from whey concentrate can be achieved by (close to 100%) further performing chromatography method after UF as taught by teachings of Heidebrecht et al. (At least in Abstract). Bottomley et al. also discloses that the UF method (MWCO 500 kDa) can be either alone also to make enriched immunoglobulin fraction (at least in col 3 lines 5-7). Therefore, examiner used Heidebrecht et al. to modify Bottomley’s UF method only to combine the teaching of including the step of using “mixed mode Chromatography” to make more pure form of immunoglobulin from “enriched immunoglobulin fraction” in order to get rid of residual proteins and contaminants from the “enriched immunoglobulin fraction
Heidebrecht et al. discloses that immunoglobulin is further purified by subjecting said UF retentate to mixed mode chromatography method using mixed mode material Mercapto -Ethyl-Pyridine-Hypercel which captures IgG followed by elution under specific condition to isolate pure, active and stable IgG (at least in Abstract, page 61, 2.3 section, 3.1 under Results and Discussion). Heidebrecht et al. also discloses that purified IgG is dried further (page 61, col 2, section 2.4). It is to be noted that applicant’s specification used identical MEP Hyper Cel Column (in PGPUB [0043]).
Heidebrecht et al., et al. also discloses the method of drying the purified IgG further (page 61, col 2, section 2.4) in order to have purified dried, stable immunoglobulin for its further application in food. Therefore, it meets claim 3.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Bottomley et al. to include the teaching of Heidebrecht et al., to consider further purification of immunoglobulin enriched UF retentate using mixed mode material Mercapto -Ethyl-Pyridine-Hypercel chromatography method which captures IgG followed by elution under specific condition to isolate pure, active and stable IgG (at least in Abstract, page 61, 2.3 section, 3.1 under Results and Discussion) followed by drying that purified IgG further (page 61, col 2, section 2.4) in order to have purified dried, stable immunoglobulin for its further application in food.
Regarding pore size, Bottomley et al. in view of Heidebrecht et al. are silent about specifically claimed pore size as claimed in claims 1 and 13.
Muronen et al. discloses that the pore size for the membrane used for UF (1-1000 kDa) can be 0.001 micron to 1.0 micron (1 nm to 1000 nm).
D1 et al. discloses that such pre size range is effective in order to physically block all microorganisms such as bacteria (about 1 μm), cysts (about 10 μm) and viruses (about 0.1 μm), the membrane of the filtration membrane 111 has a pore size of less than 1 μm, preferably less than 0.1 μm.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Bottomley et al. and Heidebrecht et al., to include the teaching of Muronen et al. discloses that the pore size for the membrane used for UF (1-1000 kDa) can be 0.001 micron to 1.0 micron ( 1 nm to 1000 nm) and such pre size range is effective in order to physically block all microorganisms such as bacteria (about 1 μm), cysts (about 10 μm) and viruses (about 0.1 μm), as disclosed by D1 et al. (page 10 , last paragraph).
Bottomley is specifically silent about “ultrafiltration can be applied in cross-flow with spiral wound module type membrane” as claimed in claims 1, 7.
Etzel et al. discloses that the ultrafiltration membrane can be applied in cross-flow (at least in [0038]) and having spiral wound module type membrane in order to maximize surface area (at least in [0038], [0040], [0041]) for better performance.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify UF method of Bottomley et al. to include the teaching of Etzel et al. to perform such a 500-1000 kDa MWCO membrane containing ultrafiltration by applying cross-flow (at least in [0038], [0039]) and having spiral wound module type membrane in order to maximize surface area (at least in Etzel et al. [0040], [0041]) for better performance.
11. Regarding claim 4, Bottomley disclose that a liquid whey protein concentrate including whey from cheese processing (i.e. cheese whey) (at least in Example 3 whey from cheddar pH 6.05) is subjected to ultrafiltration through a membrane having a preferred molecular weight cut-off of about 500 kDa directly produce an immunoglobulin enriched concentrate (col 4 lines 15-50). Therefore, it would have been obvious and it is within the skill of one of ordinary skill in the art to optimize the UF method to have desired whey protein including “at least 40% by weight of the that whey protein containing product can contain at least 40 wt.% based on total whey protein as claimed in claim 4.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of MW Cut-off in Bottomley et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. maximum retention of whey protein in the Whey protein concentrate (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
12. Regarding claims 5, 16, Bottomley et al. discloses that the pH of the liquid subjected to the ion-exchange may be from 5.5-7.0 (at least in col 4 lines 11-13). It is to be noted that the disclosed “liquid subjected to the ion-exchange resin” is the ‘ immunoglobulin enriched UF retentate” and, therefore, having pH 5.5-7.0 meets claim 5, 16. This “immunoglobulin enriched UF retentate” is subjected to mixed mode material Mercapto -Ethyl-Pyridine-Hypercel which captures IgG followed by elution under specific condition to isolate pure, active and stable IgG as disclosed by Heidebrecht et al. (at least in Abstract, page 61, 2.3 section, 3.1 under Results and Discussion). Therefore, it meets claims 5, 16.
13. Regarding claim 6, 17, it is to be noted that it would have been obvious that IgG present in casein reduced milk before subjecting to cross-flow filtration would have the amount present in cheese whey Bottomley et al. also discloses that PM500 concentrate 12.5% and permeate 2.0% and whey had a concentration of 8.6% IgG in before UF (col 6 lines 55-67, Table 3) which meets claim 6.
14. Regarding claim 15, Bottomley also disclose that about 75%, or 88% by weight of the IgG in the whey have been found to remain in the concentrate (at least in Bottomley et al. Col 4 lines 22, 28-30). It would have been obvious and it is within the skill of one of ordinary skill in the art to optimize the method to have desired amount of IgG, based on total whey protein including “50-80% by weight” based on total whey protein as claimed in claim 15. This is also optimizable.
Absent showing of unexpected results, the specific amount of MW cut-off of 500-1000 kDa is not considered to confer patentability to the claims. As the amount of IgG to be retained are variables that can be modified, among others, by adjusting the MW cut-off value of membrane, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of MW Cut-off in Etzel et al. in view of Bottomley et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. maximum retention of IgG in the Whey protein concentrates in retentate (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
15. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable Bottomley et al. USPN 5194591 in view of Etzel et al. US 2014/ 0234506 in view of Heidebrecht et al. (J Chromatography Vol 1562, pages 59-68, 2018: Posted by the applicant dated 10/20/2023) and in view of Muronen et al. (WO2017103336A1·2017-06-22) and further in view of D1 et al. as applied to claim 1 and further in view of Rubin et al. USPN 5013569 A.
16. Regarding claims 10-12, Bottomley et al. in view of Etzel et al., Heidebrecht et al., and Muronen et al. are silent about ‘a nutritional composition’ comprising the whey protein-containing product produced according to claim 1 and which is infant formula.
Rubin et al. discloses that immunoglobulin can be supplemented in infant formula in order to make infant food formulation substantially approximate human milk (at least in Abstract, col 3 lines 42-45 and in at least in col 4 lines 13-36) to meet “nutritional composition comprising the whey protein-containing product” of claim 10 and “infant formula” of claim 11. Also, Infant formula, can include carbohydrates, fats including vegetable fats, vitamins and minerals, (at least in col 4 lines 13-36) to meet claim 12.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Bottomley et al. in view of Etzel et al., Heidebrecht et al. and Muronen et al. with the teaching of Rubin et al. to incorporate immunoglobulin as nutritional supplement in infant formula in order to make infant food formulation substantially approximate human milk (at least in Abstract, col 3 lines 42-45 and in at least in col 4 lines 13-36).
17. The Examiner notes that claim 10 is product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.
The courts also held that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Furthermore, "[b]because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
Response to Arguments
18. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. As discussed above, upon review, examiner has made a new ground of rejection using Bottomley et al as primary prior to address prior claim limitation of the claimed invention of independent claim 1 in order to strengthen the rejection. Therefore, the rejection is made as non-final. As because prior arts were used, therefore, the arguments are addressed with proper response as presented below.
19. Before addressing the arguments made for the respective prior arts of record, examiner is going to make a brief discussion to address how the combined teachings of the prior arts of record meet the obviousness rejection.
It is to be noted that Etzel et al. has been considered as primary prior art because Etzel et al. is broad and discloses UF method to make [ broadly] “Whey protein concentrate” which contain few proteins mixture including immunoglobulin (IgG) (at least in claim 8 of Etzel et al.). This is considered to be purified further by performing combined chromatography treatment in combination with UF.
Bottomley discloses preferred molecular weight cut-off of about 500 kDa directly produce an immunoglobulin enriched concentrate (col 4 lines 20-25, 50-55). Bottomley is used as secondary prior art to select UF membrane having MWCO 500-1000 kDa from broadly disclosed range values of MWCO membrane of Etzel et al. (at least [0039], [0040] of Etzel et al.) in order to have an immunoglobulin enriched concentrate in the retentate fraction (Bottomley et al., col 4 lines 20-25, 50-55).
Heidebrecht et al. discloses both the UF and ‘mixed mode chromatography’ methods to purify with best yield of IgG from whey. Heidebrecht et al. discloses specifically MW cut-off value which meet claimed range value. Therefore, Heidebrecht et al. is considered as proper secondary prior art to modify Etzel in view of Bottomley to further purify immunoglobulin from immunoglobulin enriched whey fraction by using “mixed mode chromatography’ which binds specifically immunoglobulin and followed by eluting the pure immunoglobulin from the chromatography column with the removal of other proteins etc. as contaminants. Therefore, the requirements for obviousness are discussed in MPEP 2142 is made.
20. Arguments: Etzel et al.:
Applicants argued in remarks, second page that
(i) On second page , mid-section of second paragraph, “The major whey proteins in bovine milk are beta-lactoglobulin and alpha-lactalbumin. Par. [0034] of Etzel points out that these proteins account for 70-80% of total whey protein content and that other whey proteins are present is smaller amounts including immunoglobulins.
(ii) On second page, third paragraph, “According to para [0005] of Etzel, whey proteins can be concentrated by UF by removing and permitting small molecules to pass the membrane. In other words, Etzel is directed to concentrating whey proteins, not to selectively separating individual whey proteins or enriching immunoglobulins relative to other whey proteins. Etzel explicitly teaches (see, e.g., par. [0007]) that ultrafiltration is conventionally performed using membranes that retain all proteins, since allowing proteins to permeate would result in protein loss”.
(iii ) On second page fourth paragraph, “While Etzel discloses negatively charged ultrafiltration membranes with nominal MWCO values of 100-1000 kDa, Etzel makes clear that these membranes are selected to achieve low sieving coefficients, comparable to conventional 10 kDa membranes, such that a-lactalbumin and beta lactalbumin are retained in the retentate, not passed into the permeate (see, [0051], [0076]). In other words, Etzel's membranes are intentionally engineered not to fractionate whey proteins.
(iv) On second page, last paragraph, “To put it another way, Etzel teaches away from the claimed requirement that at least part of the a-lactalbumin and beta-lactoglobulin permeates the membrane, and discourages one of ordinary skill in the art from performing protein-fractionating filtration as recited in claim 1. (See, e.g., MPEP 2145 (X)(D)(2) "References Cannot Be Combined Where Reference Teaches Away from Their Combination," page 2100-339, col. 1 (Rev. 01.2024, November 2024).
In response to (i)-(iii ), it is to be noted that Bottomley et al. is used as primary prior art in this office action. However, Etzel et al. is used specifically to address that the ultrafiltration membrane can be applied in cross-flow (at least in [0038]) and having spiral wound module type membrane in order to maximize surface area (at least in [0038], [0040], [0041]) for better performance.
21. Arguments: Bottomley et al.:
Applicant’s arguments on third page in relation to Bottomley et al. is considered and summarized below.
Applicants argued on third page that
(i) “Bottomley discloses two alternative processes (see col. 3, lines 10-30). In a first process, whey is subjected to ultrafiltration using a 500 kDa membrane to directly obtain an immunoglobulin-enriched concentrate. In a second process, whey is first subjected to anion-exchange chromatography, in which immunoglobulins do not bind to the resin but instead flow through, followed by ultrafiltration.
(ii) In contrast to other whey proteins, the immunoglobulins in the processes of Bottomley are not bound by the anion exchange resin and thus form the effluent. This effluent is then, i.e. after the chromatography step, subjected to ultrafiltration.
According to col. 4, lines 48-64 of Bottomley, the enrichment with anion exchange chromatography is only necessary when using membranes with a cut-off significantly below 500 kDa. Instead, when using 500 kDa membranes, no chromatography steps have to be conducted.
(iii) A disadvantage of mixed mode chromatography is, however, the competition between lg' s and other proteins for binding to the resin. As pointed out in the present application (see page 3, lines 19-28), to mitigate this disadvantage, Applicant's claimed process starts by removing part of these competing proteins with a membrane filtration step. Such a step is not disclosed or suggested by Bottomley. In other words, even if one of ordinary skill were to consider the teachings of Bottomley in combination with the teachings of Etzel, the combination of Bottomley of Etzel would lead one of ordinary skill the art away from performing Applicant's claimed process rather than toward performing it.
In response to (i)-(iii), it is to be noted that Bottomley et al. is used as primary prior art to address UF method using the selection of “500 kDa membrane. Bottomley et al. discloses that the UF method can be either alone or in combination with anion-exchange treatment (at least in col 3 lines 5-7). Therefore, the argument (ii) above is not agreed. However, Bottomley et al. is modified further by Hans-Jergen’s mixed mode chromatography to further purify the enriched immunoglobulin fraction because enriched fraction is enriched by immunoglobulin but is still not free from all other proteins and concentrates and discussed in detail in the office action above.
22. Heidebrecht (referred to in the last Office Action as Hans-Jurgen). However examiner has used Heidebrecht et al. in this office action.
Applicant’s arguments on pages 4 and 6 in remarks made for Heidebrecht' s is considered and responded accordingly. In brief, applicant’s argued that
(i) Heidebrecht' s ultrafiltration (using 10 kDa membrane) retentate is then subjected to mixed mode chromatography in order to obtain a product enriched in immunoglobulins.
(ii) The process recited in claim 1 differs from Heidebrecht' s process in performing the ultrafiltration with a membrane having a much larger molecular weight cut-off, such that at least part of the alpha-lactalbumin and beta-lactoglobulin permeates the membrane. The effect thereof is a reduction in the amount of whey proteins that may compete with immunoglobulins in binding to the chromatography resin, resulting in a higher binding capacity and a high mass transfer of immunoglobulins to the resin. The process of the present invention is therefore not only different from but more efficient than the process of Heidebrecht in terms of producing lg-enriched whey protein products. To be sure, Heidebrecht does not disclose or suggest at least the first step of the process of claim 1, namely, protein-fractionating cross-flow filtration using a large-pore membrane that allows alpha lactalbumin and beta lactalbumin to permeate.
(iii) On page 6, paragraphs 2 and 3, applicant’s argued that it is the removal of part of the proteins in the first step of applicant’s claimed method via the permeate which is different than Heidebrecht’s method because Heidebrecht’s method serves to concentrate the protein.
In response to (i) and (ii), it is to be noted that if we consider the arguments above, Heidebrecht’s ultrafiltration (using 10 kDa membrane) retentate contains whey protein concentrate containing immunoglobulin with reasonable amounts of other proteins including more alpha and beta lactalbumin etc. compared to Bottomley’s 500 -kDa UF retentate fraction which retains predominantly immunoglobulin enriched whey protein fraction (in Bottomley et al. col 4 lines 25-35) and small size alpha and beta lactalbumin with other relatively small molecules will be in the permeate fraction. Therefore, Heidebrecht teaches that Heidebrecht’s “mixed mode chromatography” is very efficient to purify Immunoglobulin from relatively less enriched immunoglobulin containing concentrated most of the whey protein retentate fraction. Therefore, it would have been obvious that this disclosed “mixed mode chromatography” of Heidebrecht would efficiently be able to purify immunoglobulin from more enriched, less contaminants containing immunoglobulin enriched whey protein fraction because part of the proteins(e.g. lactalbumins) in the first step of applicant’s claimed method via the permeate are already removed.
Regarding the argument that “Heidebrecht does not disclose or suggest at least the first step of the process of claim 1, namely, protein-fractionating cross-flow filtration using a large-pore membrane that allows alpha lactalbumin and beta lactalbumin to permeate” is not an issue. Heidebrecht does not disclose and , therefore, is not used to address the claim limitation of claim 1(i) to make immunoglobulin enriched whey protein fraction. Heidebrecht is used to teach “mixed mode chromatography”, to purify further from immunoglobulin enriched whey protein fraction. Even if the method steps to purify pure immunoglobulin are not identical, however, that is why Heidebrecht is used as secondary prior art to teach specifically “mixed mode chromatography”.
Therefore, note that while Heidebrecht does not disclose all the features of the present claimed invention, Heidebrecht et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely “mixed mode chromatography”, to purify further from immunoglobulin enriched whey protein fraction to address the step (ii) of claim 1 , and in combination with the primary reference, discloses the presently claimed invention.
Arguments: Muronen et al. and D1 (aka referred to Sinemma et al.by the applicant ) et al.:
Applicant’s arguments on fifth page, made for Muronen et al. is considered.
In response, it is to be noted that secondary prior art by Muronen et al. is specifically used to address the claimed pore size. As mentioned in the last office action, page 7 that Muronen et al. discloses that the pore size for the membrane used for UF (1-1000 kDa) can be 0.001 micron to 1.0 micron (1nm to 1000nm) which protects contamination from microorganisms as disclosed by D1 et al. (aka Sinemma et al. as referred by the applicant). Muronen et al. does not teach the motivation for such pore size. Therefore, D1 is used to specifically to strengthen the motivation to consider this pore size which meets claimed pore size. D1 is not used and is not supposed to teach cross-flow filtration, immunoglobulin enrichment , or mixed-mode chromatography as alleged by the applicants on last paragraph, fifth page in remarks section. Therefore, their combinations are used in this respect.
However, note that while Muronen et al. does not disclose all the features of the present claimed invention, Muronen et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely the pore size of such UF membrane can be 0.001 micron to 1.0 micron as disclosed by Muronen et al., and in combination with the primary reference, discloses the presently claimed invention.
However, note that while D1 et al. does not disclose all the features of the present claimed invention, D1 et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely the pore size having 0.001 micron to 1.0 micron of such membrane protects contamination from microorganisms as disclosed by D1 et al. , and in combination with the primary reference, discloses the presently claimed invention.
Applicants do not have any further arguments.
The rejection is made as non-final.
Conclusion
23. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792