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 .
2. Applicants’ arguments and amendments filed on 5/26/2026 overcomes the rejections of record. Examiner has made a new grounds of rejection as set forth below are necessitated by applicants’ arguments but addressing prior original independent claim 1. 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Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.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 Objections
4. Claim 12 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim depends on dependent claim 10 and independent claim 1. See MPEP § 608.01(n). Even if claim 12 is considered and addressed in the office action, however, applicants are advised to amend claim 12.
Claim Rejections - 35 USC § 103
5a. 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.
5b. 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.
5c. 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.
6. Claim(s) 1-7, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heidebrecht et al. (J Chromatography Vol 1562, pages 59-68, 2018: Posted by the applicant dated 10/20/2023) in view of Bottomley et al. USPN 5194591 in view of Etzel et al. US 2014/ 0234506 and in view of Muronen et al. (WO2017103336A1·2017-06-22) and further in view of Sinnema et al. et al. JP 2010524550 A (Inventor name not in English; However, prior used D1 et al. is known as Sinnema et al., identified from English language equivalent WIPO Publication : SEE item # 17 below).
7. Regarding claims 1, 2, 7, 13, 14, Heidebrecht et al. discloses that IgG is isolated from IgG enriched colostrum having greater than 99.5% purity ( page 65, under 3.4) by using in a cost effective manner with high purity and recovery and minimal loss of activity (at least on page 60, col 1 last paragraph) by using mixed mode chromatography method with 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]). Therefore, Heidebrecht et al. meets claim limitation of “mixed mode chromatography’ of claim 1 (ii).
As discussed above, Heidebrecht et al., discloses that IgG is isolated from IgG enriched colostrum. Heidebrecht et al. also discloses the microfiltration method which leads to a "casein reduced milk" (page 60, col 2 under 2.1) prior to mixed mode chromatography method (page 60, col 2 under 2.1 and 2.2).
However, Heidebrecht et al. is silent about the isolation method to isolate enriched IgG using whey protein source which is not enriched IgG , by using specifically cross-flow filtration of casein-reduced milk using a membrane with a molecular weight cut-off (MWCO 500-1000kDa) with the removal of other ingredients like lactose, salts , and other whey proteins including alpha lactalbumin and beta lactalbumin as claimed in claim 1 (i).
Bottomley et al. discloses a method to produce a liquid whey protein concentrate including whey source from cheese processing (i.e. cheese whey ) which 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) from cheese whey in order to have an immunoglobulin enriched whey protein 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.
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).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Heidebrecht et al., to consider the teaching of Bottomley et al. to perform membrane purification step of Bottomley et al. to enrich whey protein source e.g. cheese whey enriched with IgG by eliminating other agents like lactose, other whey proteins including alpha lactalbumin, beta lactoglobulin etc. in order to make IgG enriched whey fraction (i.e. equivalent starting material colostral whey having enriched IgG, section 2.1 of Heidebrecht et al.) to make suitable for next step of mixed mode chromatography’ method to finally isolate IgG.
Regarding pore size, Heidebrecht et al., in view of Bottomley et al. is 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).
Sinnema 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 Heidebrecht et al. in view of Bottomley 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 Sinnema et al. et al. (page 10 , last paragraph).
It is to be noted that Bottomley et al. discloses the method of ultrafiltration using membrane. Heidebrecht et al. in view of 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 Heidebrecht et al. in view 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.
8. Regarding claim 3, Heidebrecht et al., et al. 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.
9. 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 Heidebrecht 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 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).
10. 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. Etzel et al. also discloses that casein-reduced swiss cheese whey may have pH 6.8, Swiss Cheese whey ([0051], [0052], [0086]) . 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.
11. Regarding claim 6, 17, Heidebrecht et al. discloses that IgG content in in milk whey is 5-15 wt.% (page 60 col 2 under 2.1). 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]). Therefore, it would have been obvious that this 5-15% IgG present in casein reduced milk before subjecting to cross-flow filtration would have the amount present in cheese whey before membrane ultrafiltration (modified to cross-flow filtration). It is evidenced by applicant’s specification that the immunoglobulin content of regular WPC and SPC is below 6 wt. %, based on total whey protein (in PGPUB [0010]).
12. 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 Heidebrecht et al. in view of Bottomley et al. and Etzel 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).
13. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Heidebrecht et al. (J Chromatography Vol 1562, pages 59-68, 2018: Posted by the applicant dated 10/20/2023) in view of Bottomley et al. USPN 5194591 in view of Etzel et al. US 2014/ 0234506 in view of Muronen et al. (WO2017103336A1·2017-06-22) and further in view of Sinnema et al. et al. as applied to claim 1 and further in view of Rubin et al. USPN 5013569 A.
14. Regarding claims 10-12, Heidebrecht et al., in view of Bottomley et al. in view of Etzel 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 Heidebrecht et al. in view of Bottomley et al. in view of Etzel 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).
15. 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 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
16. Applicant’s arguments overcome the rejections of record. Examiner has used Heidebrecht et al. as primary prior art in this office action. Bottomley et al. , Etzel et al. are used as secondary prior art. Bottomley et al. is not used as secondary prior art because Bottomley et al. discloses ultrafilteration followed by anion exchange treatment (col 4 lines 65-67 and col 5 lines 5-6). Therefore, a new ground of rejection is made using Heidebrecht et al. in view of Bottomley et al. in view of Etzel et al.
(a) Heidebrecht et al. discloses mixed mode chromatography. To purify IgG from IgG enriched colostral whey material having much higher amount of Immunoglobulin and less amount of other whey protein contaminants (page 60, col 2 under 2.1) compared to bovine milk as also evidenced by applicant’s specification (in PGPUB [0003]). However, Heidebrecht et al. also discloses the microfiltration method which leads to a "casein reduced milk" (page 60, col 2 under 2.1) prior to mixed mode chromatography method (page 60, col 2 under 2.1 and 2.2). Therefore, Heidebrecht et al. does not teach away and is combinable with Bottomley et al. and Etzel et al.
(b) However, Heidebrecht et al. is silent about the isolation method to isolate enriched IgG using whey protein source which is not enriched IgG , by using specifically cross-flow filtration of casein-reduced milk using a membrane with a molecular weight cut-off (MWCO 500-1000kDa) with the removal of other ingredients like lactose, salts , and other whey proteins including alpha lactalbumin and beta lactalbumin as claimed in claim 1 (i). Bottomley et al. and Etzel et al. is used to address claim 1(i).
(c) That is why Bottomley and Ekter et al. can be used as secondary prior arts to combine with Heidebrecht et al. to provide initial raw material having IgG enriched whey fraction with much less other whey protein as contaminants which serves as better purity with better yield of the final product.
However, as examiner maintained all prior arts, examiner is addressing arguments as presented below.
17. It is to be noted that in Remarks, first page, (and also Arguments page 16 which is Eighth page, first line) applicants noted that prior secondary prior art by D1 et al. (JP 2010524550 A) is identical to English language equivalent WO 2012148269 where Inventor’s name is Sinnema et al. Accordingly, examiner has used Sinnema et al. (JP 2010524550) in this office action.
18. Applicant’s arguments in Remarks, from second page to part of fourth page under item #1 “The Office Action Improperly Relies on Inherency In Reaching the
Conclusion of Obviousness” is considered fully and addressed below.
19. Applicant’s arguments in Remarks, on second page under #1, is fully considered and responded below.
Applicants primarily argued in this section,
(a) on second page, last two paragraphs that “ In other words, the Office Action relies on Bottomley's result that IgG, despite its sub-500 kDa molecular weight, remains in the retentate. However, the Office Action simultaneously asserts (see page 5), relying only on the 14.2 kDa and 18.3 kDa molecular weights cited in Etzel, that it is obvious that α-La and ß-Lg will pass into the permeate under those same operating conditions. Applicant respectfully disagrees.
(b) on second page last paragraph and third page first paragraph that “If size-based reasoning were reliable under Bottomley's cross-flow conditions, IgG would permeate the 500 kDa membrane (since it is sized far below 500 kDa). Because Bottomley demonstrates that IgG does not permeate, which is contrary to what size-based reasoning would predict, the Office Action provides no evidentiary basis for assuming that α-La and ß-Lg will permeate reliably or in the amounts required to yield the "permeate enriched in α-lactalbumin and ß-lactoglobulin" that claim 1(i) recites”.
In response to (a) and (b), it is to be noted that,
(i) in this office action, examiner used Heidebrecht et al. as primary prior art. Bottomley et al. , Etzel et al. are used as secondary prior art.
(i) It is to be noted that Bottomley et al. has disclosed an ultrafiltration step at about 500kDA and that Etzel et al. is combined to teach cross filtration and therefore that inherently would result in a retentate rich in IgG and permeate enriched in lactose, salts and alpha lactalbumin , beta lactoglobulin etc. The secondary prior arts by Bottomley et al. and Etzel et al. are used to modify Heidebrecht et al. to meet claimed invention of claim 1 as discussed in thisoffice action above.
20. Applicants argued in Remarks, third page, last two paragraphs that
(a) “ In other words, instead of providing evidence that α-La and ß-Lg pass through large-MWCO membranes under relevant dairy cross-flow conditions, Etzel provides the opposite evidence. To put it another way, Bottomley and Etzel undermine, rather than support, the Office Action's conclusion that Bottomley's 500 kDa cross-flow filtration inherently yields the "permeate enriched in α- lactalbumin and ß-lactoglobulin" required by claim 1(i).
(b) The present application (see page 3, lines 22-28) explains that the cross-flow filtration step producing a permeate enriched in α-La and ß-Lg serves a specific functional purpose: reducing the number of whey proteins that compete with immunoglobulins for binding to the mixed mode chromatography resin, thereby increasing binding capacity and mass transfer of immunoglobulins to the resin. Such a step is not disclosed or suggested by Bottomley. To be sure, Bottomley does not disclose that its 500 kDa UF step removes α-La or ß-Lg from the retentate, and Bottomley does not disclose any subsequent mixed mode chromatographic capture of immunoglobulins.
In response to (a), and (b), examiner does not agree.
Firstly, 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.
Secondly, it is known in this art that there are reasons for the retention of lower MW sizes using higher MWCO membrane as is also evidenced by Marshall et al. (Abstract). This is also disclosed by Etzel et al. where small lactalbumins alpha lactalbumin and beta lactoglobulin having MW only 14.2 and 18. 3 kDa para [0051])
are retained by 10 kDa MWCO by manipulating membrane with negative charge membrane ([0066], [0071]-[0076] of Etzel et al. (Discussed below). This is the reason why Bottomley and Etzel are analogous art and combinable because both the prior arts disclose the method using special membranes by which small MW molecules can be retained by higher MWCO membrane by specially membranes. Although not necessary, however, examiner provides an evidentiary reference by NPL Marshall et al. that there are reasons e.g. membrane fouling, protein interaction causing pore narrowing, etc. by which lower MW molecules are retained using higher MWCO membrane having similar 0.1- micron pore size membrane (Abstract).
Therefore, Etzel et al. does not teach away for the alleged disclosed paragraphs [0066]-[0071] as disclosed by Etzel et al. However, Etzel is not and does not need to use the teachings for these alleged paragraphs [0066]-[0076] containing embodiment . 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. Applicants argued on fourth page first paragraph that “ Bottomley et al. does not disclose that its 500 kDa UF step removes α-La or ß-Lg from the retentate, and Bottomley does not disclose any subsequent mixed mode chromatographic capture of immunoglobulins. Accordingly, Bottomley does not teach, disclose, or inherently produce an enriched permeate composition as claimed by Applicant or achieve the functional benefit that Applicant's claimed invention provides”.
In response, It is discussed above and is applicable here
22. Applicants argued in Remarks, under item #2 Fifth page, second paragraphs that “ Further to the above-discussed Bottomley's teaching away from Heidebrecht, Heidebrecht teaches away from Bottomley as discussed in more detail below. As an initial matter, Heidebrecht's experiments use colostral whey, which, as shown in Heidebrecht's Figure 1 and section 2.1, has a substantially different protein composition (by containing far more immunoglobulin and far less competing whey protein) from the cheese/acid whey disclosed in Bottomley. As such, one of ordinary skill in the art would recognize that Heidebrecht's results are not reasonably combinable with Bottomley, which teaches cheese/acid whey processing”.
In response, based on the discussion made in item # 16 above, it is applicable here to establish that they are not teaching away with respect to each other. Bottomley et al. discloses the whey concentrate containing retentate contains primarily immunoglobulin (col 4 lines 25-35) which is ‘enriched IgG containing whey concentrate” and is comparable to ‘enriched IgG’ . Heidebrecht's experiments use colostral whey which is enriched IgG and is suitable for the next step of ‘mixed mode chromatography’. Therefore, they are combinable.
23. Applicants argued in Remarks, Fourth page under item #2 that “Bottomley and Heidebrecht explicitly teaches away. Applicant’s arguments under item #2 have been considered.
In response, it is discussed above.
24. Applicants argued on sixth page under item # 3 that “Etzel Teaches Away from Protein-Fractionating Filtration and Provides No Motivation to Combine Etzel With Bottomley”.
In response, examiner used Heidebrecht et al. as primary prior art. Bottomley et al. , Etzel et al. are used as secondary prior art.
25. Applicants argued in remarks, on page 7 under item # 4 that “ Muronen and Sinnema Are Not Analogous Art for the Relevant Problem and Do Not Remedy the Deficiencies of the Primary References”.
Examiner has considered the complete arguments in this section and responded below.
In response, examiner does not agree that Muronen et al. and Sinnema et al. are impermissible non-analogous art. Muronen et al. and Sinnema et al. are not used to address other claim limitations other than claimed pore size (50-100 nm) with motivation as claimed in claim 1.
In response to applicant's argument that Muronen et al. and Sinnema et al. are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Muronen et al. is used to address pore size of the membrane (item # 10, last office action, page 7). Prior D1 et al. (aka Sinnema et al. Arguments page 16 which is Eighth page, first line) discloses the motivation that this pore size is effective to protect microorganism contamination and is applicable for the membrane pore size to be considered in such type of processing steps as was mentioned in the last office action ((item # 10, last office action, page 7). Therefore, they are analogous art.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
However, note that while Muronen et al. and Sinnema et al. does not disclose all the features of the present claimed invention, Muronen et al. and Sinnema 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 “less than 0.1-micron pore size filter is effective to protect and remove microorganism contamination”, as disclosed by Sinnema et al. and in combination with the primary reference, discloses the presently claimed invention.
26. Applicants argued in remarks, on page 8 under item # 5 that “The Examiner Has Not Identified an Adequate Motivation to Combine the References, and the Proposed Combination Is the Product of Improper Hindsight”.
Examiner has considered the complete arguments in this section and responded below.
In response, examiner used Heidebrecht et al. as primary prior art. Bottomley et al. , Etzel et al. are used as secondary prior art.
The rejection is made as non-final.
Conclusion
27. 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
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