DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is Non-Final as a result of new ground of rejection
Claim Status
Claims 1-15 are pending.
Claims 11-14 are withdrawn as being directed to a non-elected invention, the election having been made on 3/25/2025.
Claims 1-10 and 15 have been examined.
Priority
This application is a 371 of PCT/IL2020/051084 10/07/2020
PCT/IL2020/051084 has PRO 62/911,581 10/07/2019
PCT/IL2020/051084 has PRO 62/911,591 10/07/2019
PCT/IL2020/051084 has PRO 62/911,504 10/07/2019
PCT/IL2020/051084 has PRO 62/911,612 10/07/2019
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/13/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejection
The rejection of claims 2, 4-8, and 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn because the amendment to the claims overcome the rejection.
Claim Objection
Claim 2 is objected to because of the following informalities:
Claim 2 is objected to because it is an improper Markush grouping. The word “or” should be revised to “and”.
Appropriate correction is required.
New Ground of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 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 3 is unclear with respect to the unit of concentration “%”. In one interpretation, the concentration is molar concentration; in another interpretation, the concentration is weight concentration.
Appropriate correction is required.
Maintained Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
1. Claims 1, 3-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tai et al. (BioMed Research International. Volume 2016, Article ID 7123587, 12 pages, previously cited 2/25/2025) in view of Chattertonet al. (The International Journal of Biochemistry & Cell Biology 45 (2013) 1730– 1747, previously cited 5/23/2025), Dong et al. (Gene. 2017; 608:13–19, previously cited 5/23/2025) and Kelly et al. (WO 2006/099309 A2, previously cited 5/23/2025).
Claim 1 is drawn to an oral composition comprising (i) a keratin compound of keratin 1 (KRT1), (ii) beta-lactoglobulin, and (iii) at least one protein with anti-inflammatory properties for providing a synergistic effect on the human body in boosting the immune system.
Tai et al. teach “𝛽-Lactoglobulin (LG) Influences Human Immunity and Promotes Cell Proliferation” (Title) and LG plays a key role in enhancing immune responses by promoting cell proliferation through IgM receptor (Abstract; p9, Fig 5). Tai et al. teach LG also contributes to the defense against severe diseases. Sepsis and septic shock, which are often caused by bacterial infection, are systematic inflammatory responses that induce multiorgan failure and results in a high mortality rate in critically ill patients (p1, col 2, para 2). Tai et al. show whole milk obtained from a Chiayl local dairy farm comprising LG (p2, col 2, Sec 2.1 Materials). Tai et al. teach LG comprises approximately 10–15% and 50% of total milk and whey protein respectively (p6, col 2, last 2 line to p8, col 1, line 1). Tai et al. teach these components of whey protein in milk are important for radical scavenging, anti-inflammatory activities, antitumor effects, and immunostimulatory effects. These factors have been shown to regulate gut homeostasis (p6, col 1), reading on strengthening gut flora by enhancing gut-associated immunity and increasing resistance to pathogens in claim 4. Tai et al. further show whole milk comprising LG and other anti-inflammatory proteins significantly promotes cell proliferation shown as follows (p5, Fig 1).
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Although Tai et al. did not explicitly teach other beneficial proteins in the whole milk, Chatterton et al. is cited to show cow milk delivered via oral administration inherently comprising various anti-inflammatory or beneficial proteins including Alpha-lactalbumin/α-LA (p1337, col 1, 4.2.1), β-Lactoglobulin/β-LG (p1337, col 2, 4.2.2), Lactoferrin/LF (p1337, col 2, 4.2.3), Immunoglobulins/Ig comprising IgA, IgM, and IgE (p1738, col 2, 4.2.5), Enzymes of Lactoperoxidase/LP (p1738, col 2, 4.2.6), and growth factor of TGF- β (p1739, col 1, 4.2.7) summarized in Table 2 (p1735) known to one of ordinary skill in the art. Chatterton et al. further teach other bioactive proteins comprising Osteopontin/OPN (p1738, col 1, 4.2.4, last para) and Lactoperoxidase/LP (p1738, col 2, 4.2.6) in milk providing additional benefit of protective function against colitis.
Tai et al. in view of Chatterton et al. do not teach an oral composition (e.g., milk comprising various bioactive proteins shown in Chatterton’s Table) further comprising a keratin compound of KRT-1.
Dong et al. teach “Critical role of Keratin 1 in maintaining epithelial barrier and correlation of its down-regulation with the progression of inflammatory bowel disease” (Title). Dong et al. teach inflammatory bowel disease (IBD) is the result of a chronic intestinal inflammatory response usually occurred in the colon and small intestine (p13, Introduction, col 1, para 1). Dong et al. teach the levels of KRT1 protein significantly decreased in serum samples of inflammatory bowel disease patients (IBD) and KRT1 decreased in various intestinal diseases, especially in Crohn's disease and ulcerative colitis (Abstract). Dong et al. suggest KRT1 is a potential therapeutic target for IBD (p19, col 1, conclusion). Kelly et al. is further cited to show keratin can be formulated for a nutraceutical to reduce inflammation (Title) via oral administration in the form of tablet, capsule, powder, fizzy table, drink, gel (for drinking), chewing gum, dissolvable strip, lozenge, sublingual table, soluble powder or liquid (p10, para 3).
Because (a) Dong’s KRT1 is an active ingredient of keratin able to reduce inflammation via Kelly’s oral administration and (b) Tai et al. in view of Chatterton et al. teach β-Lactoglobulin/β-LG as well as multiple bioactive milk proteins comprising whey proteins, enzymes, and growth factors (See Chatterton et al. p1735, Table 2) capable of reducing various anti-inflammatory mechanisms to enhance immune , one of ordinary skill in the art would have found it obvious to combine (a) Dong’s anti-inflammatory composition comprising KRT1 with (b) the other composition taught by Tai et al. in view of Chatterton et al. comprising a mixture of anti-inflammatory proteins of milk or milk extract (dry milk powder) comprising β-Lactoglobulin/β-LG as for the same purpose to reduce inflammation and/or boost immune system. The modified milk composition taught by the combined references comprises various anti-inflammatory and/or anti-microbial proteins as well as growth factors and enzymes. Thus, it is expected for the modified milk composition to have a synergistic effect on the human body in boosting the immune system when a cow milk in a combination with another anti-inflammatory protein of keratin 1 (KRT1).
One or ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Tai’s 𝛽-Lactoglobulin with Chatterton’s milk proteins because
(a) Tai et al. teach whole milk comprising 𝛽-Lactoglobulin (LG) able to enhance immune responses by promoting cell proliferation through IgM receptor (Abstract; p9, Fig 5) and LG also contributes to the defense against severe diseases to minimize systematic inflammatory responses caused by bacterial infection (p1, col 2, para 2) and (b) Chatterton et al. is cited to show cow milk delivered via oral administration inherently comprising β-Lactoglobulin/β-LG (p1337, col 2, 4.2.2) and many other anti-inflammatory proteins summarized in Chatterton’s Table 2 (p1735) able to enhance immune mechanisms known to one of ordinary skill in the art (p1732, Fig 1; p1733, Fig 2; p1736, Fig 3), the combination would have reasonable expectation of success because both references teach an anti-inflammatory protein β-Lactoglobulin in cow’s milk.
One of ordinary skill in the art would have found it obvious to combine the composition comprising cow’s milk proteins as taught by Tai et al. in view of Chatterton et al. with keratin 1 protein (KRT1) taught by Dong et al. in view of Kelly et al. because (a) Tai et al. in view of Chatterton et al. teach an oral composition comprising various cow’s milk proteins able to reduce inflammation and/or boost immune system and (b) Dong et al. teach the levels of KRT1 protein significantly decreased in serum samples of inflammatory bowel disease patients (IBD), especially in Crohn's disease and ulcerative colitis (Abstract). Dong et al. suggest KRT1 is a potential therapeutic target for IBD (p19, col 1, conclusion). Kelly et al. is further cited to show keratin can be formulated for a nutraceutical to reduce inflammation (Title) via oral administration in various form (p10, para 3). The combination would have reasonable expectation of success because all references teach anti-inflammatory proteins.
With respect to claim 3, Kelly et al. suggest an effective amount of anti-inflammatory keratin can be 5% (p16, Example 8) or 6% (p16-17, Example 10) via oral administration. Thus, one of ordinary skill in the art would have found it obvious to administer 5% or 6% KRT1. Tai et al. teach an effective amount of LG at approximately 10–15% of total milk composition for drinking (p6, col 2, last 2 line to p8, col 1, line 1).
With respect to claim 4, Tai et al. teach these components of whey protein in milk are important for radical scavenging, anti-inflammatory activities, antitumor effects, and immunostimulatory effects. These factors have been shown to regulate gut homeostasis (p6, col 1), reading on the limitation of strengthening gut flora. Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. teach an oral composition comprising keratin, LGB, and an anti-inflammatory protein described above not repeated here. MPEP 2112.01 (II) states "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With respect to claim 5, Chatterton et al. show cow’s mink inherently comprising Lactotransferrin, synonym of Lactoferrin/LF, (p1337, col 2, 4.2.3) and growth factor of TGF- β (p1739, col 1, 4.2.7).
With respect to claim 6, Chatterton et al. show cow’s mink inherently comprising Alpha-lactalbumin/α-LA (p1337, col 1, 4.2.1) and Lactoferrin/LF (p1337, col 2, 4.2.3).
With respect to claims 7-8, Chatterton et al. show cow’s mink inherently comprising Immunoglobulins/Ig comprising IgA, IgM, and IgE (p1738, col 2, 4.2.5), Lactoperoxidase/LP (p1738, col 2, 4.2.6).
With respect to claim 9, the modified milk protein composition taught by the combined references comprises various anti-inflammatory protein and anti-microbial protein which is expected to shortening of disease or outbreak periods, diminishment of likelihood of becoming ill or a reduced number or severity of symptoms associated with diseases when inflammation and/or bacterial infection is involved.
With respect to claim 10, Chatterton et al. show cow’s mink inherently comprising colostrum (p1735, Table 2).
With respect to claim 15, the modified milk composition taught by the combined references reads on milk product, beverage, and animal food (when used for animal feed).
Applicant’s Arguments
Tai et al.
A. Tai does not disclose or suggest the claimed composition because of the following reasons (Remarks, p4, Sec 1 to p5, para 1-3):
I. There is no disclosure of keratin proteins and no multi-protein formulation
II. No teaching of anti-inflammatory protein component as claimed
III. No oral composition as claimed
IV. No "synergistic" effect as demonstrated by the claimed invention
B. Tai teaches away from the claimed combination because denatured or chemically modified LGB loses activity (Remarks, p5, last two para)
C. No motivation to combine, and no reasonable expectation of success (Remarks, p6, para 1-3).
2. Chatterton et al.
A. Chatterton never mentions keratin, KRTl, or any keratin family proteins (Remarks, p6, 2nd last para)
B. No Disclosure of the Claimed Combination (Remarks, p6, last para to p7, para 1)
C. No Teaching of Synergy (Remarks, p7, para 2)
D. Different Problem Addressed (Remarks, p7, para 3)
E. Lack of Enablement (Remarks, p7, para 4)
3. Dong et al.
A. No oral composition; no formulation; no dosing (Remarks, p8, para 1)
B. No disclosure of B-lactoglobulin or any anti-inflammatory milk protein (Remarks, p8, para 2)
C. No teaching or suggestion of synergy (Remarks, p8, para 3)
D. Different problem and field; non-analogous to claimed solution (Remarks, p8, para 4)
E. Lack of enablement toward the claimed invention (Remarks, p8, para 5)
F. There's no motivation to combine Dong with the other references (e.g., Tai, Chatterton, Badowski) because Dong is directed to the pathophysiology of IBD and genetic/cellular overexpression of KRT 1, not oral delivery of protein formulations. Thus, Dong et al. teach away from exogenous oral supplementation (Remarks, p9, para 2-4)
4. Kelly et al.
A. Kelly discloses only keratin ingredients in isolation (Remarks, p9, last para to p10, para 1).
B. No disclosure of the claimed triad of KRTI + LGB + anti-inflammatory protein (Remarks, p10, para 2).
C. No teaching of synergy (Remarks, p10, para 3).
D. Different problem addressed (Remarks, p10, last para).
E. No motivation to combine and teaching away this invention because Tai et al. (cited previously) highlights the structural fragility of β-lactoglobulin, noting that denaturation or chemical modification abolishes its immunological activity.
5. Experimental Results (Remarks, p12, Experimental Results)
6. Affidavit to support unexpected result (Exhibit A of Affidavit)
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive because applicant’s arguments are NOT in compliance of MEPE comprising at least (i) Attacking references individually where the rejections are based on combinations of references (MPEP 2145), (ii) Prior art is presumed to be operable/enabling (MPEP 2121), (iii) Rationale to combine references may be in a reference or from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent (MPEP 2144), and (iv) Unexpected results commensurate in scope with claimed invention (MPEP 716.02). See response to arguments as follows.
Applicant’s arguments 1A(I)- 1A(III) are not persuasive because the rejection is based on
Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. described above not repeated here. It is noted that 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) in MPEP 2145. Also see Rationale to combine references may be in a reference or from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent in MPEP 2144.
Applicant’s arguments 1A(IV) is not persuasive because "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) states in MPEP 2112.01. Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. teach the claimed composition; thus, the same composition must have the same property as argued by applicant. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Furthermore, see "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) in MPEP 2145.
Applicant’s arguments 1B is not persuasive because it would be obvious for one of ordinary skill in the art to use bioactive LGB for making an anti-inflammatory composition, NOT denatured and modified LGB without bioactivity as suggested by applicant. Furthermore, MPEP 2141.03 (I) defines a person of ordinary skill in the art is well defined as a person of ordinary creativity able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at ___, 82 USPQ2d at 1396. Thus, a person of ordinary skill in the art is NOT a person requiring explicitly teachings from a specific prior art reference as argued by applicant.
Applicant’s arguments 1C is not persuasive because (a) Dong’s KRT1 is an active ingredient of keratin able to reduce inflammation via Kelly’s oral administration and (b) Tai et al. in view of Chatterton et al. teach β-Lactoglobulin/β-LG as well as multiple bioactive milk proteins comprising whey proteins, enzymes, and growth factors (See Chatterton et al. p1735, Table 2) capable of reducing various anti-inflammatory mechanisms to enhance immune , one of ordinary skill in the art would have found it obvious to combine the teachings. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06. Since an individual ingredient and composition able to treat inflammation is taught by the cited prior art references, it is expected to combine different anti-inflammatory compounds and/or compositions to generate a third composition better than the separate composition before combination.
Applicant’s arguments 2A- 2B are not persuasive because the rejection is based on
Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. described above not repeated here. It is noted that 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) in MPEP 2145. Also see Rationale to combine references may be in a reference or from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent in MPEP 2144.
Applicant’s arguments 2C is not persuasive because Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. teach the claimed composition; thus, the same composition must have the same property as argued by applicant. See "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) in MPEP 2112.01. Furthermore, see "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) in MPEP 2145.
Applicant’s arguments 2D is not persuasive because (a) Dong’s KRT1 is an active ingredient of keratin able to reduce inflammation via Kelly’s oral administration and (b) Tai et al. in view of Chatterton et al. teach β-Lactoglobulin/β-LG as well as multiple bioactive milk proteins comprising whey proteins, enzymes, and growth factors (See Chatterton et al. p1735, Table 2) capable of reducing various anti-inflammatory mechanisms to enhance immune , one of ordinary skill in the art would have found it obvious to combine the teachings. See "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) in MPEP 2144.06. Furthermore, a rationale to combine references different from applicant’s is permissible. See 2144(IV).
Applicant’s arguments 2E is not persuasive because prior art is presumed to be operable/enabling according to MPEP 2121.
Applicant’s arguments 3A- 3B are not persuasive because the rejection is based on
Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. described above not repeated here. It is noted that 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) in MPEP 2145. Also see Rationale to combine references may be in a reference or from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent in MPEP 2144.
Applicant’s argument 3C is not persuasive because Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. teach the claimed composition; thus, the same composition must have the same property as argued by applicant. See "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) in MPEP 2112.01. Furthermore, see "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) in MPEP 2145.
Applicant’s argument 3D is not persuasive because (a) Dong’s KRT1 is an active ingredient of keratin able to reduce inflammation via Kelly’s oral administration and (b) Tai et al. in view of Chatterton et al. teach β-Lactoglobulin/β-LG as well as multiple bioactive milk proteins comprising whey proteins, enzymes, and growth factors (See Chatterton et al. p1735, Table 2) capable of reducing various anti-inflammatory mechanisms to enhance immune , one of ordinary skill in the art would have found it obvious to combine the teachings. See "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) in MPEP 2144.06. Furthermore, a rationale to combine references different from applicant’s is permissible. See 2144(IV).
Applicant’s argument 3E is not persuasive because prior art is presumed to be operable/enabling according to MPEP 2121.
Applicant’s argument 3F is not persuasive because (a) the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992) and (b) a rationale to combine references different from applicant’s is permissible. See 2144. Furthermore, the examiner did NOT find any evidence that that Dong et al. teach “KRT1 should NOT combine with other anti-inflammatory compound”. Thus, the argument of teaching away is not persuasive.
Applicant’s arguments 4A- 4B are not persuasive because the rejection is based on
Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. described above not repeated here. It is noted that 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) in MPEP 2145. Also see Rationale to combine references may be in a reference or from common knowledge in the art, scientific principles, art-recognized equivalents, or legal precedent in MPEP 2144.
Applicant’s argument 4C is not persuasive because Tai et al. in view of Chattertonet al., Dong et al. and Kelly et al. teach the claimed composition; thus, the same composition must have the same property as argued by applicant. See "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) in MPEP 2112.01. Furthermore, see "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) in MPEP 2145.
Applicant’s argument 4D is not persuasive because (a) Dong’s KRT1 is an active ingredient of keratin able to reduce inflammation via Kelly’s oral administration and (b) Tai et al. in view of Chatterton et al. teach β-Lactoglobulin/β-LG as well as multiple bioactive milk proteins comprising whey proteins, enzymes, and growth factors (See Chatterton et al. p1735, Table 2) capable of reducing various anti-inflammatory mechanisms to enhance immune , one of ordinary skill in the art would have found it obvious to combine the teachings. See "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) in MPEP 2144.06. Furthermore, a rationale to combine references different from applicant’s is permissible. See 2144(IV).
Applicant’s argument 4E is not persuasive because (a) the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992) and (b) a rationale to combine references different from applicant’s is permissible. See 2144. Furthermore, it would be obvious for one of ordinary skill in the art to use bioactive LGB for making an anti-inflammatory composition, NOT denatured and modified LGB without bioactivity as suggested by applicant. Furthermore, MPEP 2141.03 (I) defines a person of ordinary skill in the art is well defined as a person of ordinary creativity able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at ___, 82 USPQ2d at 1396. Thus, a person of ordinary skill in the art is NOT a person requiring explicitly teachings from a specific prior art reference as argued by applicant.
Applicant’s Arguments 5-6 are not persuasive because (a) the evidence shown as follows is not commensurate in scope of the rejected claims (b) a combined composition comprising individual anti-inflammatory agent is expected to be better than individual anti-inflammatory agent in a composition without combination.
With respect to response (a) the specific formulation shown as follows (copied from Exhibit A in Affidavit) clearly not commensurate in scope of the rejected claims.
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With respect to response (b), the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02. The bar chart merely show that a composition taught by the combined references is better than the individual ingredient in a composition taught in a reference. It is expected several anti-inflammatory agents combined together in a composition to be more effective than a single anti-inflammatory agent. The data merely prove the expected result but insufficient to demonstrate differences in results are in fact unexpected and unobvious and of both statistical and practical significance as required.
2. Claims 1-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. as applied to claims 1, 3-10, 15 and further in view of Badowski et al. (Journal of Investigative Dermatology. 2017; 137: 1914-1923, previously cited 5/23/2025).
Claim 2 is drawn to the composition further comprising a second keratin protein.
Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. teach a composition comprising keratin protein 1 (KRT1).
Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. not specify a second keratin in the composition.
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Badowski et al. teach mutations in the end domains of keratin 1 (K1) and keratin 10 (K10) are associated with keratoderma (p1914, col 2, para 2). Badowski et al. suggest keratin 1 interacting with keratin 10 to form a heterodimer and further to form a tetramer shown above (p1917, Fig 2).
Because keratin 1 interacts with its partner of keratin 10 to form a complex for keratin assembling and disassembling in regulation of cell shape (p1921, col 2, last para to p1922, col 1, para 1), one of ordinary skill in the art would have found it obvious to beneficially add keratin 10 to the composition comprising keratin 1 for enhancing keratin 1 function comprising regulating mechanical resilience on epithelial tissues (p1914, Introduction, col 1), reading on keratin 10 in claim 2.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. with Badowski’s keratin 10 because (a) Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. teach a composition comprising keratin protein 1 and (b) Badowski et al. teach keratin 10 interacting with its partner of keratin 1 to form a complex for keratin assembling and disassembling in regulation of cell shape (p1921, col 2, last para to p1922, col 1, para 1) and suggest beneficially add keratin 10 to the composition comprising keratin 1 for regulating mechanical resilience on epithelial tissues (p1914, Introduction, col 1). The combination would have reasonable expectation of success because keratin 1 is expected to complex with keratin 10 in regulation of cell shape and mechanical resilience on epithelial tissues.
Applicant’s Arguments
Badowski is directed exclusively to epidermal cell biology and structural dermatology without disclosure of oral delivery, no teaching of food, nutraceutical, or milk-based formulations, β-lactoglobulin (LGB) or any anti-inflammatory milk derived proteins (Remarks, p11. 5. Badowski et al.).
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive because the rejection is based on Tai et al. in view of Chattertonet al., Dong et al., Kelly et al. and Badowski described above not repeated here. It is noted that 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) in MPEP 2145. Badowski et al. suggest keratin 1 interacting with keratin 10 to form a complex for keratin assembling and disassembling in regulation of cell shape (p1921, col 2, last para to p1922, col 1, para 1), one of ordinary skill in the art would have found it obvious to beneficially add keratin 10 to the composition comprising keratin 1 as described above not repeated here. Also see expected beneficial results are evidence of obviousness in MPEPO 716.02.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-10 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 18 of copending Application No. 17/714,166 (the ‘166 application) in view of Tai et al. (BioMed Research International. Volume 2016, Article ID 7123587, 12 pages) in view of Chattertonet al. (The International Journal of Biochemistry & Cell Biology 45 (2013) 1730– 1747) in view of Dong et al. (Gene. 2017; 608:13–19) and in view of Kelly et al. (WO 2006/099309 A2).
Claim 1 of the ‘166 application disclosed a composition comprising at least one keratin compound and beta-lactoglobulin.
Claim 4 of the ‘166 application disclosed the keratin compound comprising KRT1-3, 4-6, 10, 12-14, 17-18, 24, 28, 33-36, 42, 75, and 77.
Claim 18 of the ‘166 application disclosed a food product comprising the composition of claim 1 selected from milk products, shakes, beverages, infant formulas, animal food and the like.
Claims 1, 4, and 18 of the ‘166 application do not specify the composition further comprising an anti-inflammatory protein.
The relevancy of Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. teach a composition as applied to claims 1, 3-10 and 15 not repeated here.
Because Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. teach a modified milk composition beneficially comprising an anti-inflammatory protein together with KRT1 and beta-lactoglobulin to enhance immune system, one of ordinary skill in the art would have found it obvious to beneficially combine the composition taught by claims 1, 4, and 18 of the ‘166 application with an anti-inflammatory protein in a modified milk composition.
Thus, claim 1, 4, and 18 of the ‘166 application in view of Tai et al. in view of Chattertonet al. in view of Dong et al. and in view of Kelly et al. are obvious to the instant claims 1-10 and 15.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive because the request of holding the rejection until he claims are otherwise found allowable does not overcome the rejection of record.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
18-January-2026
/LI N KOMATSU/ Primary Examiner, Art Unit 1658