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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19 and 44-48 in the reply filed on June 8th, 2026 is acknowledged.
Applicant’s election without traverse of one casein-derived peptide and SEQ ID NO: 1 in the reply filed on June 8th, 2026 is also acknowledged.
Claims 20-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 8th, 2026.
Priority
The instant application claims priority to 371 National Stage Application PCT/IL2022/050442, filed April 28th, 2022, under 35 U.S.C. 119(a)-(d), and claims benefit to provisional application 63180727, filed April 28th, 2021, under 35 U.S.C.119 (e). The priority date of April 28th, 2021 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) filed on March 12th, 2024 is being considered by the examiner. NPL reference #5 in the IDS filed March 12th, 2024 is not attached, and therefore, not been considered.
Claims Status
The claims listing filed on October 26th, 2023 is pending. Claims 20-43 are withdrawn from further consideration for the reasons set forth in the restriction requirement, 37 CFR 1.142(b). Claims 1-19 and 44-48 are being examined on the merits in this office action.
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 1-19 and 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-7 of U.S. Patent No. 7968513* in view of US20040197422A1 (Dorgan et al.).
* U.S. Patent No. 7968513 also qualifies as prior art as its publication date is beyond the one-year grace period. Thus, its specification is also used in the following double patenting rejections.
Regarding claim 1, ‘513 claims a:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1), wherein the phosphopeptide has a molecular weight of from about 1,000 Dalton to about 5,000 Dalton, and the composition is in the form of a ready to use sterile clear aqueous solution, substantially devoid of micelles, having a pH above 6.0, wherein the composition comprises a plurality of phosphopeptides having an average molecular weight of from about 1,000 Dalton to about 5,000 Dalton and the therapeutically effective amount is sufficient to induce transient cessation of milk production in a mammary gland of a lactating animal; induce persistent cessation of milk production in the mammary gland; treat and reverse mastitis in the mammary gland; or induce involution in the mammary gland.” [claim 1].
‘513 specifies that in some embodiments, the invention is used to treat existing mastitis as well as to non-infected mammary gland as a prophylactic treatment [Col 24 line 47]. ‘513 does not claim the composition with teat seal or its importance in mastitis.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, because teat seals help mastitis and one of ordinary skill in the art could reasonably expect for such a composition to be successful at avoiding bacterial infections while decreasing the length of the dry period and increasing milk yield and hygiene in lactating mammals.
Regarding claim 2, ‘513 further claims a composition comprising of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, wherein the phosphopeptide is selected from “the group consisting of a phosphopeptide derived from β-casein comprising an amino acid sequence as set forth in SEQ ID NO: 2; a phosphopeptide derived from αS1-casein comprising an amino acid sequence as set forth in SEQ ID NO: 3; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 4; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 5; and active fragments or derivatives thereof.” [claim 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein comprises at least one of β-casein, αS1-casein, αS2-casein, or k-casein, because teat seals help mastitis and one of ordinary skill in the art could reasonably expect for such a composition to be successful at avoiding bacterial infections while decreasing the length of the dry period and increasing milk yield and hygiene in lactating mammals.
Regarding claim 3, ‘513 further claims a composition comprising of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, wherein the phosphopeptide is selected from “the group consisting of a phosphopeptide derived from β-casein comprising an amino acid sequence as set forth in SEQ ID NO: 2; a phosphopeptide derived from αS1-casein comprising an amino acid sequence as set forth in SEQ ID NO: 3; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 4; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 5; and active fragments or derivatives thereof.” [claim 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises at least one fragment of P-casein, aS1 casein, aS2-casein, or K-casein, because teat seals help mastitis and one of ordinary skill in the art could reasonably expect for such a composition to be successful at avoiding bacterial infections while decreasing the length of the dry period and increasing milk yield and hygiene in lactating mammals.
Regarding claim 4, ‘513 claims a composition comprising at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (instant SEQ. ID NO:1), wherein the phosphopeptide derived from casein is obtained by hydrolysis of casein [claim 3]. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a casein hydrolysate.
Regarding claim 5, ‘513 claims a:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1)…” [claim 1].
Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a phosphopeptide.
Regarding claim 6, ‘513 claims a:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1)…” [claim 1].
Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises an amino acid sequence selected from the group consisting of instant SEQ ID NO: 1 to SEQ ID NO: 26, because ‘513’s composition claims an amino acid sequence comprising of instant SEQ ID NO: 1.
Regarding claim 7, ‘513 does not claim the limitations of claim 7. However, Dorgan specifies that “it is believed that the oil-based formulations of the present invention enhance the effectiveness of the seal formulation in situ and offer improved compatibility with the seal in the teat canal relative to aqueous formulations” [0007]. One of ordinary skill in the art can reasonably infer that Dorgan’s teat seal forms a physical barrier as it functions “in situ” or “in place.” Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition forms a physical barrier on a teat surface, in a teat canal, or in a teat cistern of an animal because Dorgan’s composition forms a physical barrier in the teat canal as it stays in its position, compared to aqueous formulations. There would have been a reasonable expectation that such a teat seal would be successful at preventing bacterial infections.
Regarding claim 8, ‘513 does not claim the limitations of claim 8. However, Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim1]. However, Dorgan discloses other treatments available in the prior art which attempt to prevent mastitis occurring or to treat the symptoms of mastitis. “Thus, teat dip compositions are disclosed in U.S. Pat. No. 5,211,961, which are used as antibacterial washes for cleaning the teats. Alternatively, EP 1104233 and EP 799047 disclose film-forming compositions which can be applied to the teat to provide a barrier to the entry of bacterial agents” [0002]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition is formulated as a dip, a hydrogel, or a biofilm. It would have been obvious to try a teat dip or a film-forming composition that Dorgan has identified as predictable solutions to mastitis, with a reasonable expectation of success of preventing bacterial infections.
Regarding claim 9, ‘513 does not claim the limitations of claim 9. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a heavy metal.
Regarding claim 10, ‘513 does not claim the limitations of claim 10. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a non-toxic heavy metal salt.
Regarding claim 11, ‘513 does not claim the limitations of claim 11. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is bismuth [claims 1 and 3]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof, wherein the non-toxic heavy metal salt is selected from the group consisting of bismuth salt, titanium salt, zinc salt, barium salt, and any combination thereof.
Regarding claim 12, ‘513 does not claim the limitations of claim 12. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is present in an amount of from 40% to 80% by weight of the gel base [claims 1, 3, and 5]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises 40 to 80% by weight heavy metal salt.
Regarding claim 13, ‘513 claims:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1)…” [claim 1].
‘513 further claims the composition comprising from about 10 ng/ml to about 15 mg/ml of the phosphopeptide [claim 6]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the casein-derived peptide composition comprises between 10 ng/ml to 500 mg/ml of the at least one casein-derived peptide.
Regarding claim 14, ‘513 does not claim the casein protein or casein-derived peptide and teat seal composition in the same composition, but specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the same composition because ‘513 states that the its invention can be co-administered with a bactericide in a single composition and Dargan’s teat seal is anti-bacterial.
Regarding claim 15, ‘513 does not claim the casein protein or casein-derived peptide and teat seal composition in different compositions, but specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the same composition because ‘513 states that the its invention can be administered with a bactericide in separate compositions and Dargan’s teat seal is anti-bacterial.
Regarding claim 16, ‘513 does not claim the casein protein or casein-derived peptide and teat seal composition are administered separately, but specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the separate compositions because ‘513 states that the its invention can be administered with a bactericide in separate compositions and Dargan’s teat seal is anti-bacterial.
Regarding claim 17, ‘513 does not claim the casein protein or casein-derived peptide and teat seal composition are administered together, but specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are coadministered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the same composition because ‘513 states that the its invention can be co-administered with a bactericide in a single composition and Dargan’s teat seal is anti-bacterial.
Regarding claim 18, ‘513 does not claim the combination further comprising a pharmaceutical carrier, but specifies that the pharmaceutical composition may further comprise a pharmaceutically acceptable diluent, excipient or carrier [Col 17 line 22]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition further comprise a pharmaceutical carrier.
Regarding claim 19, ‘513 claims:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1)…” [claim 1].
‘513 further claims the composition wherein the pH of said composition is in the range of from about 6.0 to about 8.0 [claims 1 and 7]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition is in the range of between about 6.5 to about 9.0.
Regarding claim 44, ‘513 claims a:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1), wherein the phosphopeptide has a molecular weight of from about 1,000 Dalton to about 5,000 Dalton, and the composition is in the form of a ready to use sterile clear aqueous solution, substantially devoid of micelles, having a pH above 6.0, wherein the composition comprises a plurality of phosphopeptides having an average molecular weight of from about 1,000 Dalton to about 5,000 Dalton and the therapeutically effective amount is sufficient to induce transient cessation of milk production in a mammary gland of a lactating animal; induce persistent cessation of milk production in the mammary gland; treat and reverse mastitis in the mammary gland; or induce involution in the mammary gland.” [claim 1].
‘513 specifies that in some embodiments, the invention is used to treat existing mastitis as well as to non-infected mammary gland as a prophylactic treatment [Col 24 line 47]. ‘513 does not claim the composition with teat seal or its importance in mastitis.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition in a method for:(a) treating, preventing, inhibiting, reducing, eliminating, protecting or delaying the onset of a mammary gland disorder; (b) reducing the length of the dry period; (c) increasing the milk yield; (d) increasing the milk hygiene; (e) enhancing involution; (f) increasing the rate of involution; (g) increasing the cow's comfort (h) improving the livestock welfare; or (i) any combination of (a), (b), (c), (d) (e), (f), (g) and (h). because teat sealants avoid bacterial infections when administering as one of ordinary skill in the art could reasonably expect for such a combination to be successful at a) avoiding bacterial infections in lactating mammals’ b) reducing the length of the dry period; c) increasing the milk yield; and d) increasing the milk hygiene.
Regarding claim 45, ‘513 does not teach the limitations of claim 45, but specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition. This is because ‘513 states that the its invention can be administered with a bactericide in separate compositions and Dargan’s teat seal is anti-bacterial. One of ordinary skill in the art would also find it prima facie obvious that in order to administer ‘513’s and Dorgan’s compositions separately, they have to be in separate containers.
Regarding claim 46, ‘513 does not teach the limitations of claim 46, but specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition, wherein the first container or the second container are a syringe.
Regarding claim 47, ‘513 does not teach the limitations of claim 47, but specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. One of ordinary skill in the art would find it prima facie obvious that in order to administer ‘513’s and Dorgan’s compositions together, they would have to be in the same container. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least one container, the container comprising both the composition comprising the at least one casein protein or at least one casein-derived peptide and the teat seal composition. This is because ‘513 states that the its invention can be administered with a bactericide in separate compositions and Dargan’s teat seal is anti-bacterial.
Regarding claim 48, ‘513 does not teach the limitations of claim 48, but specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least one container, the container comprising both the composition comprising the at least one casein protein or at least one casein-derived peptide and the teat seal composition, wherein the container is a syringe. This is because for teat seal and casein-derived peptide to be administered together, they would have to be in the same container and for the combination to be injected as ‘513 demonstrated with the casein hydrolysate, the container would have to be a syringe of some form.
Claims 1-19 and 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12, and 20 of U.S. Patent No. 9220751 in view of US20040197422A1 (Dorgan et al.).
* U.S. Patent No. 9220751 also qualifies as prior art as its publication date is beyond the one-year grace period. Thus, its specification is also used in the following double patenting rejections.
Regarding claim 1, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
‘751 does not claim the composition with teat seal or its importance.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, because combined, both the teat seal and at least one casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 2, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the at least one casein peptide comprises one or more peptide fragments of β-casein, αS1-casein, αS2-casein, κ-casein [claim 2]. Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein comprises at least one of β-casein, αS1-casein, αS2-casein, κ-casein, because combined, both the teat seal and casei protein perform the same function of treating bacterial infections, as they do separately.
Regarding claim 3, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the at least one casein peptide comprises one or more peptide fragments of β-casein, αS1-casein, αS2-casein, κ-casein [claim 2]. Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises at least one fragment of β-casein, αS1-casein, αS2-casein, κ-casein, because combined, both the teat seal and casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 4, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the at least one casein peptide is a casein hydrolysate [claim 3]. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a casein hydrolysate.
Regarding claim 5, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the at least one casein peptide comprises a phosphopeptide [claim 4]. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a phosphopeptide.
Regarding claim 6, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the at least one casein peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5 and SEQ ID NO:6 [claim 5]. ‘751’s SEQ ID NO: 2-4 all comprise of instant SEQ ID NO: 1. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises an amino acid sequence selected from the group consisting of instant SEQ ID NO: 1 to SEQ ID NO: 26.
Regarding claim 7, ‘751 does not teach the limitations of claim 7. However, Dorgan specifies that “it is believed that the oil-based formulations of the present invention enhance the effectiveness of the seal formulation in situ and offer improved compatibility with the seal in the teat canal relative to aqueous formulations” [0007]. One of ordinary skill in the art can reasonably infer that Dorgan’s teat seal forms a physical barrier as it functions “in situ” or “in place.” Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition forms a physical barrier on a teat surface, in a teat canal, or in a teat cistern of an animal because Dorgan’s composition forms a physical barrier in the teat canal as it stays in its position, compared to aqueous formulations. There would have been a reasonable expectation that such a teat seal would be successful at preventing bacterial infections.
Regarding claim 8, ‘751 does not teach the limitations of claim 8. However, Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. However, Dorgan discloses other treatments available in the prior art which attempt to prevent mastitis occurring or to treat the symptoms of mastitis. “Thus, teat dip compositions are disclosed in U.S. Pat. No. 5,211,961, which are used as antibacterial washes for cleaning the teats. Alternatively, EP 1104233 and EP 799047 disclose film-forming compositions which can be applied to the teat to provide a barrier to the entry of bacterial agents” [0002]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition is formulated as a dip, a hydrogel, or a biofilm. It would have been obvious to try a teat dip or a film-forming composition that Dorgan has identified as predictable solutions to mastitis, with a reasonable expectation of success of preventing bacterial infections.
Regarding claim 9, ‘751 does not teach the limitations of claim 9. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a heavy metal
Regarding claim 10, ‘751 does not teach the limitations of claim 10. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a non-toxic heavy metal salt.
Regarding claim 11, ‘751 does not teach the limitations of claim 11. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is bismuth [claims 1 and 3]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof, wherein the non-toxic heavy metal salt is selected from the group consisting of bismuth salt, titanium salt, zinc salt, barium salt, and any combination thereof.
Regarding claim 12, ‘751 does not teach the limitations of claim 12. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is present in an amount of from 40% to 80% by weight of the gel base [claims 1, 3, and 5]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises 40 to 80% by weight heavy metal salt.
Regarding claim 13, ‘751 further claims the method of treatment of an uterine infection comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, wherein the amount of said at least one casein peptide effective to treat said uterine infection is between 10 ng/ml to 500 mg/ml [claim 20]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the casein-derived peptide composition comprises between 10 ng/ml to 500 mg/ml of the at least one casein-derived peptide.
Regarding claim 14, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
‘751 specifies,
“An acceptable carrier is a pharmaceutically and physiologically acceptable carrier and is to be understood as a carrier or an excipient that is generally safe, non-toxic and neither biologically nor otherwise undesirable. A pharmaceutically acceptable carrier as used in the specification and claims includes either one or more than one of such carriers. The carrier can be any of those conventionally used and is limited only by chemico-physical considerations, such as solubility and lack of reactivity with the at least one casein peptide, and by the route of administration” [Col 7 line 54].
By the broadest reasonable interpretation, Dorgan’s teat seal is a pharmaceutical carrier. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the same composition because ‘751 states that the its invention can have a pharmaceutical carrier and a teat sealant can be a carrier.
Regarding claim 15, ‘751’s method of treatment comprises a composition with at least one casein peptide [claim 1]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately comprised in different compositions, but perform the same function. It is prima facie obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in different compositions.
Regarding claim 16, 751’s method of treatment comprises a composition with at least one casein peptide [claim 1]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately separate, but perform the same function. It is prima facie obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are administered separately.
Regarding claim 17, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
The instant recitation “are administrated together” is an intended use recitation. The recitation does not limit the scope of the combination of compositions itself, and therefore does not have a limiting effect on the scope of the claim [MPEP 2103 (I) (C)]. Therefore, it was prima facie obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are administered together because ‘751 states that the its invention can have a pharmaceutical carrier and teat sealant can be a carrier.
Regarding claim 18, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition further comprise a pharmaceutical carrier.
Regarding claim 19, ‘751 does not claims the limitations of claim 19, but specifies that the range of 6.7 to 6.9 was found to be the most suitable pH for topical or parenteral administration of casein peptides [Col 8 line 6]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition is in the range of between about 6.5 to about 9.0.
Regarding claim 44, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
‘751 also states that the present disclosure provides a kit comprising at least one casein peptide and instructions for use the casein peptide for the treatment of a uterine infection in a female mammalian animal [Col 1 line 66]. ‘751 does not claim the kit with teat seal or its importance.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition in a method for:(a) treating, preventing, inhibiting, reducing, eliminating, protecting or delaying the onset of a mammary gland disorder; (b) reducing the length of the dry period; (c) increasing the milk yield; (d) increasing the milk hygiene; (e) enhancing involution; (f) increasing the rate of involution; (g) increasing the cow's comfort (h) improving the livestock welfare; or (i) any combination of (a), (b), (c), (d) (e), (f), (g) and (h). because teat sealants avoid bacterial infections when administering as one of ordinary skill in the art could reasonably expect for such a combination to be successful at a) avoiding bacterial infections in lactating mammals; g) increasing the cow’s comfort, and h) improving livestock welfare.
Regarding claim 45, ‘751’s method of treatment comprises a composition with at least one casein peptide [claim 1]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately separate and have to be in some kind of container. It is prima facie obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition.
Regarding claim 46, ‘751 claims administration by injection or infusion [claim 12]. In the examples, the casein hydrolysates were injected [Col 13 line 43]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition, wherein the first container or the second container are a syringe.
Regarding claim 47, ‘751 claims a:
“method for treatment of an uterine infection, the method comprising transcervical intrauterine administration to a female livestock mammalian animal in need of treatment of uterine infection, an amount of at least one casein peptide, the amount being effective to treat an uterine infection in the mammalian animal, wherein said administration of the at least one casein peptide is in combination with a pharmaceutical carrier providing said transcervical intrauterine administration of the at least one casein peptide.” [claim 1].
‘751 specifies,
“An acceptable carrier is a pharmaceutically and physiologically acceptable carrier and is to be understood as a carrier or an excipient that is generally safe, non-toxic and neither biologically nor otherwise undesirable. A pharmaceutically acceptable carrier as used in the specification and claims includes either one or more than one of such carriers. The carrier can be any of those conventionally used and is limited only by chemico-physical considerations, such as solubility and lack of reactivity with the at least one casein peptide, and by the route of administration” [Col 7 line 54].
By the broadest reasonable interpretation, Dorgan’s teat seal is a pharmaceutical carrier. One of ordinary skill in the art would find it prima facie obvious that ‘751’s and Dorgan’s compositions are then in the same container. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least one container, the container comprising both the composition comprising the at least one casein protein or at least one casein-derived peptide and the teat seal composition.
Regarding claim 48, ‘751 claims administration by injection or infusion [claim 12]. In the examples, the casein hydrolysates were injected [Col 13 line 43]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least one container, the container comprising both the composition comprising the at least one casein protein or at least one casein-derived peptide and the teat seal composition, wherein the container is a syringe.
Claims 1-12, and 15-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14-17, 26, and 36-39 of copending Application No. 19130551 in view of Dorgan et al. (US20040197422A1).
Regarding claim 1, ‘551 claims a:
“method for treating intramammary infection in lactating mammals during lactation, comprising administering to said lactating mammals a composition comprising at least one milk-derived protein, wherein said lactating mammal cure period occurs during the same lactation.” [claim 1].
‘551 further claims the method,
“wherein said milk derived protein comprises a casein protein or casein derived peptide” [claim 9]
‘551 does not claim the method with a composition with teat seal or its importance.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, because combined, both the teat seal and at least one casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 2, ‘551 further claims the method of treatment for an intramammary infection, wherein said milk derived protein comprises a casein protein or casein derived peptide, wherein said casein-derived peptide comprises one or more fragments of β-casein, αS1-casein, αS2-casein, or κ-casein [claims 1, 9, and 13]. Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein comprises at least one of β-casein, αS1-casein, αS2-casein, or κ-casein, because combined, both the teat seal and at least one casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 3, ‘551 further claims the method of treatment for an intramammary infection, wherein said milk derived protein comprises a casein protein or casein derived peptide, wherein said casein-derived peptide comprises one or more fragments of β-casein, αS1-casein, αS2-casein, κ-casein [claims 1, 9, and 13]. Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises at least one of β-casein, αS1-casein, αS2-casein, or κ-casein, because combined, both the teat seal and at least one casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 4, ‘551 further claims the method of treatment for an intramammary infection, wherein said milk derived protein comprises a casein protein or casein derived peptide, wherein said casein-derived peptide comprises a casein hydrolysate, phosphopeptide or combination thereof [claims 1, 9, and 15]. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a casein hydrolysate.
Regarding claim 5, ‘551 further claims the method of treatment for an intramammary infection, wherein said milk derived protein comprises a casein protein or casein derived peptide, wherein said casein-derived peptide comprises a casein hydrolysate, phosphopeptide or combination thereof [claims 1, 9, and 15]. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises a phosphopeptide.
Regarding claim 6, ‘551 further claims the method of treatment for an intramammary infection, wherein said milk derived protein comprises a casein protein or casein derived peptide, wherein said casein-derived peptide comprises a casein hydrolysate, phosphopeptide or combination thereof, wherein said phosphopeptide comprises an amino acid sequence selected form the group consisting of SEQ ID NO. 1 - SEQ ID NO. 26. [claims 1, 9, and 15-16]. ‘551’s SEQ ID NO: 1-26 correspond to instant SEQ ID NO: 1-26. Therefore, it would have been obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein-derived peptide comprises an amino acid sequence selected from the group consisting of instant SEQ ID NO: 1 to SEQ ID NO: 26.
Regarding claim 7, ‘551 does not teach claims the limitations of claim 7. However, Dorgan specifies that “it is believed that the oil-based formulations of the present invention enhance the effectiveness of the seal formulation in situ and offer improved compatibility with the seal in the teat canal relative to aqueous formulations” [0007]. One of ordinary skill in the art can reasonably infer that Dorgan’s teat seal forms a physical barrier as it functions “in situ” or “in place.” Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition forms a physical barrier on a teat surface, in a teat canal, or in a teat cistern of an animal because Dorgan’s composition forms a physical barrier in the teat canal as it stays in its position, compared to aqueous formulations. There would have been a reasonable expectation that such a teat seal would be successful at preventing bacterial infections.
Regarding claim 8, ‘551 does not teach claims the limitations of claim 8. However, Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. However, Dorgan discloses other treatments available in the prior art which attempt to prevent mastitis occurring or to treat the symptoms of mastitis. “Thus, teat dip compositions are disclosed in U.S. Pat. No. 5,211,961, which are used as antibacterial washes for cleaning the teats. Alternatively, EP 1104233 and EP 799047 disclose film-forming compositions which can be applied to the teat to provide a barrier to the entry of bacterial agents” [0002]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition is formulated as a dip, a hydrogel, or a biofilm. It would have been obvious to try a teat dip or a film-forming composition that Dorgan has identified as predictable solutions to mastitis, with a reasonable expectation of success of preventing bacterial infections.
Regarding claim 9, ‘551 does not teach claims the limitations of claim 9. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a heavy metal
Regarding claim 10, ‘551 does not teach claims the limitations of claim 10. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base [claim 1]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof because Dorgan teaches a teat seal composition comprising a non-toxic heavy metal salt.
Regarding claim 11, ‘551 does not teach claims the limitations of claim 11. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is bismuth [claims 1 and 3]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises a non-toxic heavy metal, or salt thereof, wherein the non-toxic heavy metal salt is selected from the group consisting of bismuth salt, titanium salt, zinc salt, barium salt, and any combination thereof.
Regarding claim 12, ‘551 does not teach claims the limitations of claim 12. However, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is present in an amount of from 40% to 80% by weight of the gel base [claims 1, 3, and 5]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the teat seal composition comprises 40 to 80% by weight heavy metal salt.
Regarding claim 15, ‘551’s method of treatment comprises a composition with a casein peptide [claims 1 and 9]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately comprised in different compositions, but perform the same function. It is prima facie obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in different compositions.
Regarding claim 16, 551’s method of treatment comprises a composition with a casein peptide [claims 1 and 9]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately separate, but perform the same function. It is prima facie obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are administered separately.
Furthermore, the instant recitation “are administrated separately” is an intended use recitation. The recitation does not limit the scope of the combination of compositions itself, and therefore does not have a limiting effect on the scope of the claim [MPEP 2103 (I) (C)].
Regarding claim 17, the instant recitation “are administrated together” is an intended use recitation. The recitation does not limit the scope of the combination of compositions itself, and therefore does not have a limiting effect on the scope of the claim [MPEP 2103 (I) (C)].
Therefore, it was prima facie obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are administered together because ‘751 states that the its invention can have a pharmaceutical carrier and teat sealant can be a carrier.
Regarding claim 44, ‘551 claims a:
“method for treating intramammary infection in lactating mammals during lactation, comprising administering to said lactating mammals a composition comprising at least one milk-derived protein, wherein said lactating mammal cure period occurs during the same lactation.” [claim 1].
‘551 further claims the method,
“wherein said milk derived protein comprises a casein protein or casein derived peptide” [claim 9]
‘551 does not claim the method with a kit with teat seal or its importance.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition in a method for:(a) treating, preventing, inhibiting, reducing, eliminating, protecting or delaying the onset of a mammary gland disorder; (b) reducing the length of the dry period; (c) increasing the milk yield; (d) increasing the milk hygiene; (e) enhancing involution; (f) increasing the rate of involution; (g) increasing the cow's comfort (h) improving the livestock welfare; or (i) any combination of (a), (b), (c), (d) (e), (f), (g) and (h). because teat sealants avoid bacterial infections when administering as one of ordinary skill in the art could reasonably expect for such a combination to be successful at a) avoiding bacterial infections in lactating mammals; g) increasing the cow’s comfort, and h) improving livestock welfare.
Regarding claim 45, ‘551’s method of treatment comprises a composition with a casein peptide [claims 1 and 9]. Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim 1]. These two compositions are innately separate and have to be in some kind of container. It is prima facie obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition.
Claims 13-14, 18-19, and 46-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14-17, 26, and 36-39 of copending Application No. 19130551 in view of Dorgan et al. (US20040197422A1) in further view of Iscovich et al. (US7968513B2; published 2011).
Regarding claim 13, ‘551 claims a:
“method for treating intramammary infection in lactating mammals during lactation, comprising administering to said lactating mammals a composition comprising at least one milk-derived protein, wherein said lactating mammal cure period occurs during the same lactation.” [claim 1].
‘551 further claims the method,
“wherein said milk derived protein comprises a casein protein or casein derived peptide” [claim 9]
‘551 does not claim the method with a composition with teat seal or its importance.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Both ‘551 and Dorgan do not claim or teach a composition with 10 ng/mL to 500 mg/mL of at least one casein-derived peptide.
Iscovich et al. provide an invention related to peptides derived from casein and their use in the management of lactating animals, particularly to methods for decreasing the length of the dry period of a lactating livestock animal, for increasing its milk yield and milk hygiene after parturition and for improving the livestock welfare [Abstract line 1]. Iscovich et al. claims A pharmaceutical composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1), comprising from about 10 ng/ml to about 15 mg/ml of the phosphopeptide [claim 1 and 6]. Iscovich et al. specifies that the preferred method of administration is into a teat canal of a lactating animal [Col 6 line 40]. In some embodiments, the invention is used to treat existing mastitis as well as to non-infected mammary gland as a prophylactic treatment [Col 24 line 47].
Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the casein-derived peptide composition comprises between 10 ng/ml to 500 mg/ml of the at least one casein-derived peptide to improve livestock welfare.
Regarding claim 14, both ‘551 and Dorgan do not claim or articulate a combined composition. Iscovich et al. specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition and the teat seal composition are comprised in the same composition, as taught by Iscovich.
Therefore, prior to the effective filing date, it would have been obvious to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, because combined, both the teat seal and at least one casein peptide perform the same function of treating bacterial infections, as they do separately.
Regarding claim 18, both ‘551 and Dorgan do not claim or teach a composition with a pharmaceutical carrier. Iscovich specifies that the pharmaceutical composition may further comprise a pharmaceutically acceptable diluent, excipient or carrier [Col 17 line 22]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition further comprise a pharmaceutical carrier, as Iscovich teaches ‘551’s composition with a pharmaceutical carrier.
Regarding claim 19, both ‘551 and Dorgan do not claim or teach a composition with a pH of about 6.5 to 9.0. Iscovich claims:
“a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (SEQ. ID NO:1)…” [claim 1].
‘513 further claims the composition wherein the pH of said composition is in the range of from about 6.0 to about 8.0 [claims 1 and 7]. Therefore, it was obvious, prior to the effective filing date, to claim a combination, comprising: (i) a composition comprising at least one casein protein or casein-derived peptide; and (ii) a teat seal composition, wherein the at least one casein protein or casein-derived peptide composition or the teat seal composition is in the range of between about 6.5 to about 9.0, as Iscovich teaches ‘551’s composition with a pH of 6 to 8.
Regarding claim 46, ‘551 and Dorgan do not claim or teach a container that is a syringe. Iscovich et al. specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, prior to the effective filing date, it would have been obvious to claim a kit comprising (i) a composition comprising at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition, comprising at least two separate containers, first container comprising the composition comprising the at least one casein protein or at least one casein-derived peptide, and the second container comprising the teat seal composition, wherein the first container or the second container are a syringe.
Regarding claim 47, ‘551 and Dorgan do not claim or teach a container with both at least one casein protein or casein-derived peptide and a teat seal composition.
Iscovich et al. specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, it would have been obvious, prior to the effective filing date to administer Iscovich’s casein-derived peptide and Dorgan’s antibacterial teat seal composition together. One of ordinary skill in the art would also find it prima facie obvious that in order to administer Iscovich’s and Dorgan’s compositions together, they would have to be in the same container.
Regarding claim 48, ‘551 and Dorgan do not claim or teach a container that is a syringe. Iscovich et al. specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, it would have been obvious, prior to the effective filing date, for teat seal and casein-derived peptide to be administered together, they would have to be in the same container and for the combination to be injected as Iscovich demonstrated with the casein hydrolysate, the container would have to be a syringe of some form.
This is a provisional nonstatutory double patenting rejection.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities: the word “administrated” is used instead of “administered”. Appropriate correction is required.
Claim 44 is objected to because of the following informalities: the use of the article “the” in points (b) through (h) is misleading because subject that follows has not been established before. While one of ordinary skill in the art knows what the article “the” is referring to, there is a lack of antecedent basis for the subject. Proposed claim language is:
“(b) reducing dry period length
(c) increasing milk yield
(d) increasing milk hygiene
(e) increasing involution rate
(f) increasing a cow’s comfort
(g) improving livestock welfare; or”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19, 44-45, and 47 are rejected under 35 U.S.C. 101 because the claimed composition is a product of nature without any markedly different characteristics from any naturally occurring counterparts:
Laws of nature and natural phenomena, as identified by the courts, include
naturally occurring principles/relations and nature-based products that are
naturally occurring or that do not have markedly different characteristics
compared to what occurs in nature. The courts have often described these
exceptions using other terms, including "physical phenomena," "scientific
principles", "natural laws," and "products of nature." [MPEP 2106.04(c)]
Regarding claim 1, claim 1 recites “casein protein or casein-derived peptide” and “teat seal”, which are both products of nature. See analysis below.
Step 1: Does the claim fall into a statutory category of invention?
Yes, the claim is directed to a composition of matter, which falls into a category of invention.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
Yes, the claim is directed to a product of nature because the casein proteins and casein-derived peptides can be derived from a cow’s milk (Hassanin, A. A., Osman, A., Atallah, O. O., El-Saadony, M. T., Abdelnour, S. A., Taha, H. S. A., Awad, M. F., Elkashef, H., Ahmed, A. E., Abd El-Rahim, I., Mohamed, A., & Eldomiaty, A. S. (2022). Phylogenetic comparative analysis: Chemical and biological features of caseins (alpha-S-1, alpha-S-2, beta- and kappa-) in domestic dairy animals. Frontiers in veterinary science, 9, 952319) [pg 2 pgh 2] and the broadest reasonable interpretation of a teat seal includes the keratin plug naturally formed by cows when daily milking stops and the dry period begins [pg 2 line 4 and pg 3 line 5] (To seal or not to seal? (2019, March 1). AGProud. https://www.agproud.com/articles/37993-to-seal-or-not-to-seal). Thus, the at least one casein protein or casein-derived peptide and teat seal composition are products individually found in nature
Furthermore, during the period of colostrum formation, both the cow’s milk and keratin plug are present together (Swinkels, J., & Boersma, R. (2010). The Dry Cow Period Step-By-Step. In The Cattle Site. https://www.thecattlesite.com/articles/2464/the-dry-cow-period-step-by-step) [Recharging udder health section colostrum formation]. Towards the calving date, milk pressure builds up, putting pressure on the keratin plug and causing milk leakage.
The markedly different characteristic analysis is part of Step 2A: Prong One. The
markedly different characteristic analysis compares the nature-based product limitation
to its naturally occurring counterpart in its natural state, the first step in the analysis is
to select the appropriate counterpart(s) to the nature-based product.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or
natural phenomenon?
In the present case, the answer is yes because when a nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the
counterpart. Section 2106.04 (b) recites:
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590- 91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they claim “naturally occurring phenomena" and are "squarely within the law of nature exception")
Step 2A Prong Two: Does the claim recite additional elements that integrate
the judicial exception into a practical application?
Because the markedly different characteristics analysis is based on comparing the
characteristics of the claimed nature-based product and its counterpart, the second step
in the analysis is used to identify appropriate characteristics to compare. Appropriate
characteristics must be possessed by the claimed product, because it is the claim that
must define the invention to be patented. In the present case, each component found in
nature is unmodified by a defining quantity like a commercial teat seal composition.
Regarding claims 2 and 3, alpha-S-1, alpha-S-2, beta, and kappa casein are found in bovine milk [Hassanin et al pg 2 pgh 2].
Regarding claim 4, casein is found in bovine milk.
Regarding claim 5, phosphopeptides are found in milk casein [Hassanin et al pg 2 pgh 5].
Regarding claim 6, the anionic triplet embedded in the bioactive peptide
(SerP–SerP–SerP–Glu–Glu) is a distinguishing property of every casein phosphopeptide and comprises of instant SEQ ID NO: 1 [Hassanin et al pg 2 pgh 5].
Regarding claim 7, the keratin plug forms a physical barrier in the teat canal.
Regarding claim 8, the keratin plug falls under the broadest reasonable interpretation of a biofilm.
Regarding claims 9 and 10, non-toxic heavy metals are products of nature.
Regarding claim 11, bismuth, titanium, zinc, and barium salts are products of nature.
Regarding claim 12, a teat seal composition comprising 40 to 80% by weight heavy metal salt does not possess markedly different characteristics [MPEP 2106.05 (c)]. There is no evidence in the record that the percentage of heavy metal salt claimed changes the functional characteristics of a teat sealant. A combination with bovine milk and a composition with a keratin plug and heavy metal salt reads on a product of nature as the composition has not been markedly changed.
Regarding claim 13, the approximate casein composition of milk is (mg/mL): α-s1 (12-15); α-s2 (3-4); β (9-11); and κ (2-4) (Casein from bovine milk. (n.d.). Sigma. https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/137/877/c7078pis.pdf?srsltid=AfmBOorcTzMZJMSvGeTZ6Z2IHtE-QPkf4YlCN21_bTJGXCVjRrQSpW2i). This translates to 26-34 mg/mL of casein in bovine milk. Therefore, 10ng/mL to 500 mg/mL of a casein-derived peptide in a composition reads on a product of nature.
Regarding claim 14, during the period of colostrum formation, both the cow’s milk and keratin plug are present together (Swinkels et al) [Recharging udder health section colostrum formation]. Towards the calving date, milk pressure builds up, putting pressure on the keratin plug and causing milk leakage. Thus, towards the calving date, the casein proteins and teat seal are together in the udder.
Regarding claim 15, bovine milk and keratin plugs are separate once the milk has left the cow’s udder.
Regarding claims 16 and 17, the recitations “administrated separately” and “administrated together” are intended use recitations that do not limit the scope of the combination claimed [MPEP 2103 (I) (C)]. Therefore, the claim reads on a product of nature.
Regarding claim 18, the broadest reasonable interpretation of a pharmaceutical carrier includes products of nature, such as water.
Regarding claim 19, the pH of fresh cow milk is between 6.5 to 6.7 (Anne Marie Helmenstine, Ph.D. (2022). What is the pH of milk? In ThoughtCo. https://www.thoughtco.com/what-is-the-ph-of-milk-603652) [pgh 2]. Thus, a casein protein or casein-derived peptide composition is a product of nature.
Regarding claim 44, casein proteins and casein-derived peptides can be derived from a cow’s milk (Hassanin et al) [pg 2 pgh 2] and the broadest reasonable interpretation of a teat seal includes the keratin plug naturally formed by cows when daily milking stops and the dry period begins (AGProud) [pg 2 line 4 and pg 3 line 5]. Thus, the at least one casein protein or casein-derived peptide and teat seal composition are products individually found in nature.
Regarding claim 45, once bovine milk has exited the cow, the milk and keratin plug are in separate containers.
Regarding claim 47, during the period of colostrum formation, both the cow’s milk and keratin plug are present together (Swinkels et al) [Recharging udder health section colostrum formation]. Towards the calving date, milk pressure builds up, putting pressure on the keratin plug and causing milk leakage. Therefore, the claimed kit is a product of nature because the udder is a container comprising casein proteins and a keratin plug.
Claims 46 and 48 are objected to for dependency on rejected base claims 45 and 47, respectively.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 44-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a kit comprising (i), (ii), and optional (iii), for use of the kit in a method for (a)-(i) through intramammary administration, does not reasonably provide enablement for a kit comprising (i), (ii), and optional (iii), for use of the kit in a method for (a)-(i), The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claim encompasses anything that has both a casein protein or casein-derived peptide and a teat seal composition, like a cow, as the word “kit” in the preamble qualifies as reciting an intended use of the compositions [MPEP 2111.02 (II)]. The nature of invention is something that can be found naturally occurring in a cow during a dry period. Casein proteins are found in cow’s milk (Hassanin et al) [pg 2 pgh 2] and the broadest reasonable interpretation of a teat seal includes the keratin plug naturally formed by cows when daily milking stops and the dry period begins (AGProud) [pg 2 line 4 and pg 3 line 5]. During the period of colostrum formation, both the cow’s milk and keratin plug are present together (Swinkels et al) [Recharging udder health section colostrum formation]. Towards the calving date, milk pressure builds up, putting pressure on the keratin plug and causing milk leakage.
Therefore, the state of the prior art shows that a kit comprising a composition comprising (i) at least one casein protein or at least one casein-derived peptide, (ii) a teat seal composition reads on a cow during the dry period. One of ordinary skill in the art would not find possible that a cow is able to be used in a method for (a) treating, preventing, inhibiting, reducing, eliminating, protecting or delaying the onset of a mammary gland disorder; (b) reducing the length of the dry period; (c) increasing the milk yield; (d) increasing the milk hygiene; (e) enhancing involution; (f) increasing the rate of involution; (g) increasing the cow's comfort (h) improving the livestock welfare; or (i) any combination of (a), (b), (c), (d) (e), (f), (g) and (h) in another mammal. Nor, is there any predictability in the art.
The inventor provides direction by determining the prevention of intramammary infections post-calving, after dry-off therapy by intramammary administration of casein protein or casein-derived peptides following internal teat sealant compared to drying off treatment with internal teat sealing alone [000144]. The working examples support intramammary administration [000146]. There would be an undue amount of experimentation necessary to use the kit based on the contents of the disclosure. Thus, the applicant is solely enabled for a kit comprising (i), (ii), and optional (iii), for use of the kit in a method for (a)-(i) through intramammary administration.
Claims 45 and 47 are rejected because using containers to separate or combine the casein protein or casein-derived peptide and teat seal composition do not enable the invention to be used in its complete scope of using the kit in a method for (a)-(i).
Claims 46 and 48 are rejected because the claimed addition of a syringe is not limited to intramammary administration and can be used in a kit that is not enabled for the complete scope in a method for (a)-(i).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
In the reply filed on June 8th, 2026, applicant elected the species of one casein-derived peptide and SEQ ID NO: 1. The following rejection is based on the election.
Claims 1-19 and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Iscovich et al. (US7968513B2; published 2011) in view of Dorgan (US20040197422A1).
Iscovich et al. provide an invention related to peptides derived from casein and their use in the management of lactating animals, particularly to methods for decreasing the length of the dry period of a lactating livestock animal, for increasing its milk yield and milk hygiene after parturition and for improving the livestock welfare [Abstract line 1]. Iscovich et al. claims a composition comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, the elected casein-derived peptide [claim 1]. Iscovich et al. specifies that the preferred method of administration is into a teat canal of a lactating animal [Col 6 line 40]. In some embodiments, the invention is used to treat existing mastitis as well as to non-infected mammary gland as a prophylactic treatment [Col 24 line 47]. Iscovich does not claim the composition with teat seal or its importance in mastitis.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to add teat sealant in a combination comprising instant SEQ ID NO: 1 when administering a composition in a teat canal because teat seals help mastitis and one of ordinary skill in the art could reasonably expect for such a composition to be successful at avoiding bacterial infections while decreasing the length of the dry period and increasing milk yield and hygiene in lactating mammals.
Regarding claims 2 and 3, Iscovich et al. goes on to claim a composition comprising of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, wherein the phosphopeptide is selected from “the group consisting of a phosphopeptide derived from β-casein comprising an amino acid sequence as set forth in SEQ ID NO: 2; a phosphopeptide derived from αS1-casein comprising an amino acid sequence as set forth in SEQ ID NO: 3; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 4; a phosphopeptide derived from αS2-casein comprising an amino acid sequence as set forth in SEQ ID NO: 5; and active fragments or derivatives thereof.” [claim 2]. Iscovich’s SEQ ID NO: 2-5 all comprise of instant SEQ ID NO: 1 (the elected species).
Therefore, prior to the effective filing date, it would have been obvious to use a β-casein, αS1-casein, or αS2-casein-derived peptide, such as one comprising instant SEQ ID NO: 1. to decrease the length of the dry period of a lactating livestock animal and increase its milk yield and hygiene.
Regarding claim 4, Iscovich claims a composition comprising at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu (instant SEQ. ID NO:1), wherein the phosphopeptide derived from casein is obtained by hydrolysis of casein [claim 3].
Regarding claims 5 and 6, the composition claimed by Iscovich comprises of at least one phosphopeptide comprising instant SEQ ID NO: 1 [claim 1].
Regarding claim 7, Dorgan specifies that “it is believed that the oil-based formulations of the present invention enhance the effectiveness of the seal formulation in situ and offer improved compatibility with the seal in the teat canal relative to aqueous formulations” [0007]. One of ordinary skill in the art can reasonably infer that Dorgan’s teat seal forms a physical barrier as it functions “in situ” or “in place.” Therefore, it was obvious, prior to the effective filing date, that Dorgan’s composition forms a physical barrier in the teat canal as it stays in its position, compared to aqueous formulations.
Regarding claim 8, Dorgan’s composition comprises of a gel-based seal formulation and oil-based antibacterial agent [claim1]. However, Dorgan discloses other treatments available in the prior art which attempt to prevent mastitis occurring or to treat the symptoms of mastitis. “Thus, teat dip compositions are disclosed in U.S. Pat. No. 5,211,961, which are used as antibacterial washes for cleaning the teats. Alternatively, EP 1104233 and EP 799047 disclose film-forming compositions which can be applied to the teat to provide a barrier to the entry of bacterial agents” [0002]. Therefore, it would have been obvious to try a teat dip or a film-forming composition that Dorgan has identified as predictable solutions to mastitis, with a reasonable expectation of success of preventing bacterial infections.
Regarding claims 9 and 10, Dorgan’s composition comprises of a non-toxic heavy metal salt [claim 1].
Regarding claim 11, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is bismuth [claims 1 and 3]. Therefore, prior to the effective filing date, it would have been obvious to one of ordinary skill in art to use a bismuth salt as the non-toxic heavy metal salt for a reasonable expectation of success at preventing bacterial infections in lactating animals.
Regarding claim 12, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein the non-toxic heavy metal salt is present in an amount of from 40% to 80% by weight of the gel base [claims 1, 3, and 5]. Therefore, prior to the effective filing date, it would have been obvious to one of ordinary skill in art to use 40-80% by weight heavy metal salt for a reasonable expectation of success at preventing bacterial infections in lactating animals.
Regarding claim 13, Iscovich et al, claim a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, the elected casein-derived peptide, comprising from about 10 ng/ml to about 15 mg/ml of the phosphopeptide [claim 1 and 6]. Therefore, prior to the effective filing date, it would have been obvious to one of ordinary skill in art to use about 10 ng/ml to about 15 mg/ml of the phosphopeptide for a reasonable expectation of success at decreasing the length of the dry period of a lactating livestock animal and for increasing its milk yield and milk hygiene.
Regarding claims 14 and 15, Iscovich et al. specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it would be obvious to either administer Dorgan’s anti-bacterial teat seal in a combined composition with Iscovich’s phosphopeptide composition; or administer them in separate compositions, as taught by Iscovich.
Regarding claim 16, Iscovich et al. specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, it would have been obvious, prior to the effective filing date to administer Iscovich and Dorgan’s compositions separately as Iscovich et al. teach that their invention can be administered before or after an anti-microbial treatment, like Dorgan’s teat sealant.
Regarding claim 17, Iscovich et al. specifies that “the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are coadministered, either as a combined, single pharmaceutical composition or as separate compositions” [Col 24 line 51]. Therefore, it would be obvious to administer Dorgan’s anti-bacterial teat seal together with Iscovich’s phosphopeptide composition, as Iscovich suggested.
Regarding claim 18, Iscovich specifies that the pharmaceutical composition may further comprise a pharmaceutically acceptable diluent, excipient or carrier [Col 17 line 22].
Regarding claim 19, Iscovich et al, claim a composition comprising a therapeutically effective amount of at least one phosphopeptide derived from casein comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, the elected casein-derived peptide, wherein the pH of said composition is in the range of from about 6.0 to about 8.0 [claims 1 and 7]. The instant pH range encompasses Iscovich’s range. Therefore, it would have been obvious to have the casein-derived peptide composition in a pH range of 6.5 to 9 for the most reasonable expectation of being successful at decreasing the length of the dry period of a lactating livestock animal and for increasing its milk yield and hygiene.
Regarding claim 44, Iscovich et al. provide an invention related to peptides derived from casein and their use in the management of lactating animals, particularly to methods for decreasing the length of the dry period of a lactating livestock animal, for increasing its milk yield and milk hygiene after parturition and for improving the livestock welfare [Abstract line 1]. Iscovich et al. claims a composition comprising the amino acid sequence Ser(p)-Ser(p)-Ser(p)-Glu-Glu, the elected casein-derived peptide [claim 1]. Iscovich et al. specifies that the preferred method of administration is into a teat canal of a lactating animal [Col 6 line 40], and in some embodiments, the invention is used to treat existing mastitis as well as to non-infected mammary gland as a prophylactic treatment [Col 24 line 47]. Iscovich does not claim the composition with teat seal or its importance in treating mastitis.
Dorgan teaches a composition for the prophylaxis and treatment of mastitis in mammals, preferably cows [Abstract line 1]. Dorgan states that the it is well established that bacterial infection via the teats of a cow is the most common cause of mastitis [0002]. An important property of an ideal teat seal is that the seal should be capable of remaining in situ for the duration of the dry cow period [0006]. Thus, Dorgan claims a composition comprising an antibacterial formulation and a separate seal formulation, wherein the antibacterial formulation contains an antibacterial agent in an oil-based formulation and the seal formulation comprises a gel base and a non-toxic heavy metal salt in the base in an amount of at least 30% by weight of the gel base, wherein said antibacterial formulation and said seal formulation are blended into a single formulation intended to be administered to the teat canal of a non-human animal directly in one step [claims 1 and 2].
Therefore, prior to the effective filing date, it would have been obvious to make a kit comprising a composition with Iscovich’s casein-derived peptide and Dorgan’s teat sealant in a composition comprising instant SEQ ID NO: 1 because teat sealants avoid bacterial infections when administering as one of ordinary skill in the art could reasonably expect for such a combination to be successful at a) avoiding bacterial infections in lactating mammals’ b) reducing the length of the dry period; c) increasing the milk yield; and d) increasing the milk hygiene.
Regarding claim 45, Iscovich et al. specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, it would have been obvious, prior to the effective filing date to administer Iscovich’s and Dorgan’s compositions separately. One of ordinary skill in the art would also find it prima facie obvious that in order to administer Iscovich’s and Dorgan’s compositions separately, they have to be in separate containers.
Regarding claim 46, Iscovich et al. specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, it would have been obvious, prior to the effective filing date to have the first container comprising the casein-derived peptide to be a syringe so that it can be injected during treatment.
Regarding claim 47, Iscovich et al. specifies that the novel pharmaceutical composition of the present invention is administered in combination with an additional anti-microbial treatment selected from the group consisting of, but not limited to, antibiotic, bactericide, steroidal and non-steroidal anti-inflammatory treatment, treatment with an immunomodulator and vaccination. According to one embodiment, the pharmaceutical composition of the present invention and the additional anti-microbial treatment are co-administered, either as a combined, single pharmaceutical composition or as separate compositions. Alternatively, the pharmaceutical composition of the present invention is administered as a pre-treatment followed by the application of the additional anti-microbial treatment, and vise-versa [Col 24 line 51]. Therefore, it would have been obvious, prior to the effective filing date to administer Iscovich’s casein-derived peptide and Dorgan’s antibacterial teat seal composition together. One of ordinary skill in the art would also find it prima facie obvious that in order to administer Iscovich’s and Dorgan’s compositions together, they would have to be in the same container.
Regarding claim 48, Iscovich et al. specifies that administration to the teat canal can be by way of injection or infusion [Col 6 line 40]. In the examples provided to demonstrate the shortening of the dry period, casein hydrolysate was administered by injection into a gland cistern through the teat canal of the mammary gland [Col 29 line 49]. It is prima facie obvious that an injection requires a syringe of some form. Therefore, it would have been obvious, prior to the effective filing date, for teat seal and casein-derived peptide to be administered together, they would have to be in the same container and for the combination to be injected as Iscovich demonstrated with the casein hydrolysate, the container would have to be a syringe of some form.
Conclusion
Claims 1-19 and 44-48 are rejected on the ground of nonstatutory double patenting. Claims 1-19 and 44-48 are rejected on the ground of provisional nonstatutory double patenting. Claims 16-17 and 44 are objected to. Claims 1-19, 44-45, and 47 are rejected under 35 U.S.C. 101. Claims 44-45 and 47 are rejected under 35 U.S.C. 112(a). Claims 1-19 and 44-48 are rejected under 35 U.S.C. 103. Claims 46 and 48 are objected to for dependency on rejected base claims.
Correspondence
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/SACHI JAUHARI/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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