Detailed Action
Preliminary Amendment
1. Entry of applicant’s preliminary amendment dated 11-8-23 into the application file is acknowledged.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 14-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the dissolution" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 incorporates claim 1 and claim 14 positively recites the clip is a weasand clip, but claim 1 does not positively recite a weasand clip in that claim 1 only requires the device has sufficient tensile strength to be used as a weasand clip and therefore it is unclear to whether a weasand clip is being claimed since incorporated claim 1 does not positively claim a weasand clip.
Claim Rejections - 35 USC § 102
3. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2023/0394993 to Burton.
Referring to claim 1, Burton discloses a device for livestock processing comprising, polyvinyl alcohol (PVA) – see for example paragraphs [0020]-[0027], wherein the PVA dissolves in water or aqueous media at a temperature of 20 to 130°C in 45 minutes or less – see for example figure 5 and paragraphs [0024]-[0027], and wherein the device has a tensile strength suitable for use as a weasand clip – see figures 4A-4C where the device is used as a livestock clip and therefore has a tensile strength suitable for this use and suitable to be used as any similar type of clip for livestock use such as a weasand clip. It is noted that applicant has not positively recited the weasand clip in the claim.
Referring to claim 2, Burton further discloses a device for livestock processing, consisting of – see figure 2, or consisting essentially of – see figure 2, polyvinyl alcohol (PVA) – see paragraphs [0020]-[0027] detailing the device can be made of PVA and see paragraphs [0155]-[0156] detailing the device – at 2,3 can be made entirely of the same material such as those disclosed in paragraph [0020], wherein the PVA dissolves in water or aqueous media at a temperature of 20 to 130°C in 45 minutes or less – see figure 5 and paragraphs [0024]-[0027], and wherein the device has a tensile strength suitable for use as a weasand clip – see figures 2 where the device is used as a livestock clip and therefore has a tensile strength suitable for this use and suitable to be used as any similar type of clip for livestock use such as a weasand clip. It is noted that applicant has not positively recited the weasand clip in the claim.
Referring to claim 5, Burton further discloses the PVA dissolves in water or aqueous media at a temperature of 127o C – see figure 5 and paragraphs [0024]-[0027].
Referring to claim 8, Burton further discloses the PVA further comprises one or more additives selected from the group consisting of: talc, silica, clays, starch, cellulose, keratin, chitin, chitosan, polylactic acid, polyhydroxyalkanoates, and calcium carbonate – see starch in paragraph [0020].
Claim Rejections - 35 USC § 103
4. 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.
Claim(s) 3-4, 6 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton as applied to claim 1 above.
Referring to claim 3, Burton does not disclose the PVA has a degree of hydrolysis of 50-100 mol%. However, applicant has not placed any criticality to using this claimed range for the degree of hydrolysis as seen in paragraphs [0023]-[0025] of applicant’s originally filed specification and therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and use any suitable degree of hydrolysis for the PVA material including the claimed degrees of hydrolysis, so as to yield the predictable result of making the device of suitable strength and durability as desired.
Referring to claim 4, Burton further discloses the PVA device dissolves in water at above normal environmental temperatures as seen in paragraph [0024], but does not specifically disclose dissolving at a temperature of 25oC in 45 minutes or less. However, it would have been obvious to one of ordinary skill in the art to take the device of Burton and make the device dissolve at a temperature of 25oC in 45 minutes or less, so as to yield the predictable result of ensuring the device does not interfere with further processing of the livestock as desired.
Referring to claim 6, Burton does not disclose the dissolution of the PVA is measured according to the Polymer Pellet Dissolution Test using a pellet consisting of the PVA. However, it would have been obvious to one of ordinary skill in the art to measure the dissolution via any suitable analysis including the claimed polymer pellet dissolution test, so as to yield the predictable result of ensuring the material used for the device has the desired properties for its use.
Referring to claim 10, Burton does not disclose wherein the PVA has a glass transition temperature of 35°C or greater. However, applicant places no criticality on the glass transition temperature being 35oC or greater as seen in paragraph [0021] of applicant’s originally filed specification and therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and use any suitable glass transition temperature including the claimed 35oC or greater, so as to yield the predictable result of ensuring the material used for the device has the desired properties for its use so as to make the device of sufficient durability.
Referring to claim 11, Burton does not disclose the PVA dissolves at a rate of 5 g/min. However, applicant places no criticality on the dissolving rate of 5 g/min as seen in paragraph [0014] of applicant’s originally filed specification and therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and have the PVA dissolve at any suitable rate including the claimed 5 g/min, so as to yield the predictable result of ensuring the device does not interfere with further processing of the livestock as desired.
Referring to claim 12, Burton does not disclose the PVA has a number average molecular weight (Mn) of 100 kDa. However, applicant places no criticality on the average molecular weight being 100kDa as seen in paragraph [0026] of applicant’s originally filed specification and therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and have the PVA material with any suitable average molecular weight including the claimed average molecular weight of 100kDa, so as to yield the predictable result of ensuring the material used for the device has the desired properties for its use so as to make the device of sufficient durability.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2010/0297458 to Khemani et al.
Referring to claim 7, Burton does not disclose the PVA comprises one or more plasticizers. Khemani et al. does disclose the PVA comprises one or more plasticizers – see paragraphs [0014], [0019] and [0023]. Therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and add the plasticizer(s) of Khemani et al., so as to yield the predictable result of making the device of sufficient strength and durability as desired.
Referring to claim 9, Burton does not disclose the PVA has a tensile strength of at least 1 MPa. Khemani et al. does disclose the PVA has a tensile strength of at least 1 MPa – see paragraph [0019]. Therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and add the tensile strength of at least 1 MPa of Khemani et al., so as to yield the predictable result of making the device of sufficient strength and durability as desired.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton as applied to claim 1 above, and further in view of U.S. Patent No. 6,190,249 to Karubian.
Referring to claim 13, Burton does not disclose the device is a weasand clip or weasand plug. Karubian does disclose the device is a weasand clip – see at 34 in figures 5-11. Therefore it would have been obvious to one of ordinary skill in the art to take the device of Burton and have the device as any suitable clip device including the weasand clip of Karubian, so as to yield the predictable result of allowing the user to use the clip for any suitable purpose on livestock as desired.
Claim(s) 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Karubian.
Referring to claim 14, Burton discloses a method of livestock processing comprising, providing a clip according to the device of claim 1 – see rejection of claim 1 detailed earlier, slaughtering the animal to produce a carcass – see paragraphs [0038], [0044], [0109], [0120], [0132]-[0133], [0136], [0141], [0153], [0209]-[0211], [0217]-[0218], [0228] and [0230]-[0231], detailing scalding techniques where the animal is slaughtered prior to this step, and dissolving the clip – see paragraphs [0020]-[0027], wherein a food product produced from the carcass is free of or substantially free of particulate matter derived from the weasand clip – see paragraphs [0020]-[0027] and [0155]-[0156] where the device can be entirely made of dissolvable material and therefore any food product would be free of particulate matter from the clip. Burton does not disclose the clip is a weasand clip that prevents or substantially prevents contamination of the carcass from the livestock animal’s gut contents. Karubian does disclose the clip – at 34, is a weasand clip – see figures 5-11, that prevents or substantially prevents contamination of the carcass from the livestock animal’s gut contents – see column 1 lines 10-20 and column 4 lines 14-48. Therefore it would have been obvious to one of ordinary skill in the art to take the method of Burton and add the clip being a weasand clip preventing contamination from the animal’s gut contents, so as to yield the predictable result of ensuring the animal is in sufficient condition for further processing as desired.
Referring to claim 15, Burton as modified by Karubian further discloses the weasand clip is dissolved in a rendering step – see for example paragraphs [0020]-[0027, [0155]-[0156] and [0038], [0044], [0109], [0120], [0132]-[0133], [0136], [0141], [0153], [0209]-[0211], [0217]-[0218], [0228], [0230]-[0231] of Burton.
Referring to claim 16, Burton as modified by Karubian further discloses the rendering step is performed at a temperature of 16. 127°C for a time of at least 45 min – see for example paragraphs [0020]-[0027] of Burton.
Referring to claim 17, Burton as modified by Karubian further discloses the livestock animal is cattle – see for example paragraph [0120] of Burton.
Referring to claim 18, Burton as modified by Karubian further discloses the PVA is a PVA copolymer of PVA and one or more second polymers – see for example paragraph [0020] of Burton.
Referring to claim 19, Burton as modified by Karubian further discloses the one or more second polymers in the PVA copolymer is formed from one or more of the following monomers: acrylic acid, methacrylic acid, crotonic acid, itaconic acid, maleic acid, fumaric acid, vinyl sulfonic acid, allyl sulfonic acid, ethylene sulfonic acid, 2-acrylamido-1-methylpropanesulfonic acid, 2-acrylamido-2- methylpropanesulfonic acid, 2-methylacrylamido-2-methylpropanesulfonic acid, or 2-sulfoethyl acrylate – see methacrylic acid in paragraph [0020] of Burton.
Referring to claim 20, Burton as modified by Karubian further discloses the PVA copolymer is a copolymer of PVA and one or more of, a polyethyleneimine, a polyvinyl pyrrolidone, a pullulan, a guar gum, a xanthan gum, a carrageenan, a starch, a ethoxylated starch, a hydroxyethylated starch, a hydroxypropylated starch, a carboxymethylated starch, a polyalkylene oxid, a polyacrylamide, a cellulose, a cellulose ether, a cellulose ester, a cellulosic amide, a polyamino acid, a polyamide, a gelatin, a methylcellulose, a carboxymethylated cellulose, or a maltodextrin – see starch in paragraph [0020] of Burton.
Referring to claim 21, Burton as modified by Karubian does not disclose the molar percent ratio of the total amount of the second polymer(s) in the PVA copolymer is 1-20% of the second polymer(s) relative to PVA. However, applicant places no criticality on the molar percent ratio of the second polymer(s) being 1-20% as seen in paragraph [0031] of applicant’s originally filed specification and therefore it would have been obvious to one of ordinary skill in the art to take the method of Burton as modified by Karubian and use any suitable molar percent ratio of the second polymer(s) including the claimed 1-20% molar percent ratio, so as to yield the predictable result of ensuring the material used for the device has the desired properties for its use so as to make the device of sufficient durability.
Conclusion
5. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following patents are cited to further show the state of the art with respect to clips and/or weasand clips in general:
U.S. Pat. No. 4,320,557 to Speedie – shows weasand clip
U.S. Pat. No. 4,343,066 to Lance – shows weasand clip
U.S. Pat. No. 8,540,741 to Rodrigues – shows weasand clip
WIPO No. 2014/072963 to Maritini – shows clip device
FR 3055191 to Rodriguez – shows weasand clip
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J PARSLEY whose telephone number is (571)272-6890. The examiner can normally be reached Monday-Friday, 8am-4pm EST.
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/DAVID J PARSLEY/Primary Examiner, Art Unit 3643