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 with traverse of Group I (claims 1-17) in the reply filed on 2/5/2026 is acknowledged. The traversal is on the ground(s) that each of the claims goes beyond the type of “purified cotyledonary placental extract” described in the cited Nardid et al., and alleged that the restriction requirement is improper per MPEP803. This is not found persuasive because the restriction requirement is based on MPEP1875 (unity of invention) as the instant application is a national stage application rather than a national application which is limited to MPEP chapter 800. The restriction requirement of a national stage application, i.e. a 371 application, is based on lack of unity of invention, and as discussed in the restriction requirement, the technical feature shared by the groups of inventions of the instant application is not considered as a “special” technical feature. Thus, the unity of invention is lacking per teachings of Nardid et al.
It is noted that the restriction requirement was based on the interpretation of “cotyledonary placenta” as cotyledons of a placenta including human placenta, hence human placenta taught by Nardid et al. was considered to break the unity. However, under further consideration, the term “cotyledonary placenta” is now considered to limit non-human mammals as in cow, sheep, deer, etc. Thus, Nardid et al. is not a proper prior art. Rather, the technical feature shared by the groups of inventions is taught by Corbel et al. or JP H06234798 A (see below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-54 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-17 have been considered on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5 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 4 discloses the term “unique” in line 2. It is not clear what subject matter this term intends to point out. As claim 4 is dependent on claim 3 which requires the placenta being bovine, does this mean that the composition comprises proteins unique to bovine that are not in other species or “unique” in other sense, like structurally unique? Without defining how the proteins are unique, the claim is considered indefinite.
Claim 5 recites the limitation "the two most prevalent protein clusters in the purified composition" in lines 1-2. It is not clear what the term “clusters” is referring to as the claim listed two proteins, vimentin and actin, and they are not in clusters. As the term “clusters” is understood as a group of proteins that share significant sequence or structure, and yet the exemplified protein is not a cluster of protein, rather individual protein, it is not clear what the term “clusters” points out.
Claim Interpretation
Claim 1 is a product-by-process claim. Claims 2-17 depend from said claims. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. “[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
The steps of claim 1 require specific agents in each step as claimed in the dependent claims (e.g. claims 6-12), however, there is no indication that these agents (e.g. ionic buffer, protease neutralizing reagent, linearization buffer) are either present in the resulting composition except the soluble proteins from cotyledonary placenta or provide any specific structure in the claimed product other than purified soluble proteins from cotyledonary placenta including bovine placenta.
Based on the above discussion, claims 1-12 are interpreted as a composition comprising soluble proteins extracted from cotyledonary placenta including bovine placenta.
Claims 13 requires a sterilization step, and thus, the resulting product is interpreted as a sterilized composition comprising soluble proteins of cotyledonary placenta.
Claim 14 requires a step of drying, and the resulting product is interpreted as a dried composition comprising soluble proteins of cotyledonary placenta.
Claims 15-17 are considered the same as claim 1 as the limitation directed to the steps being conducted in a controlled environment of at least ISO level 8 does not provide any structural feature to the claimed product.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. product of nature, without significantly more. The claim(s) recite(s) a purified composition comprising soluble proteins from cotyledonary placenta. The claims are directed to a statutory category, e.g., a composition of matter (Step 1:YES). Because the claims are directed to a composition comprising soluble proteins extracted from cotyledonary placenta and the ingredients, i.e. soluble proteins, of the compositions are nature-based products, the nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. In this case, a cotyledonary placenta including bovine placenta is considered as a naturally occurring counterpart as the soluble proteins of the claimed product are extracted from the naturally occurring placenta. There is no indication in the specification that the claimed composition of naturally occurring products has any characteristics (structural, functional or otherwise) that are different from naturally occurring counterparts. Thus, the combination of the claimed invention does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claims are directed to a judicial exception (Step 2A Prong 1:YES).
It is noted that the claims are product-by-process claims, and MPEP2106.04(c)(I)(B) states that for a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart. Thus, the elements utilized in the process steps of the instant claims are not considered unless the structure of the resulting product is significantly different due to the method steps. As discussed in the claim interpretation above, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2A prong 2:NO).
This judicial exception is not integrated into a practical application because there is no additional element that would integrate the judicial product into any improvement in their function or the use of a particular treatment or applying or using the judicial exception in some other meaningful way. Thus, the judicial exception is not integrated into a practical application (STEP 2A Prong Two: NO).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no additional element that render the claimed product significantly more than the judicial exception (STEP 2B: NO).
Based on the above discussion, the instant claims are not directed to the subject matter eligible under 101.
Claim Rejections - 35 USC § 102/103
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 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.
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) 1-12 and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Corbel et al. (1973, Br. Vet. J.).
Corbel et al. teach water soluble extracts of bovine placental cotyledons (p.lxxvi). Corbel et al. teach the aqueous extracts were prepared from the fetal cotyledon tissue of fresh bovine placentas by homogenizing in distilled water followed by centrifugation and then filtration (preparation of extracts for growth assay).
Regarding claims 4-5 directed to the purified composition comprising between 647 and 740 unique proteins including vimentin and actin, Corbel et al. do not particularly teach the limitation. However, as the water-soluble extracts of bovine placenta taught by Corbel et al. are considered identical to the claimed composition, it is expected that the extracts of Corbel et al. would inherently contain the claimed proteins in the absence of evidence to the contrary.
Regarding claim 14 directed to the additional step of drying including lyophilizing, this step provides the structure of the composition being lyophilized, i.e. freeze-dried. Corbel et al. teach the aqueous extracts of bovine placenta was freeze-dried before the reconstituting to a final concentration in distilled water (p.lxxvi). This teaching is considered to meet the structure of claim 14 as a freeze-dried composition.
As discussed above, the steps disclosed in the claims do not provide any specific structure to the claimed composition comprising soluble proteins of the bovine placenta.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' composition differs, and if so to what extent, from the aqueous extracts of bovine placenta discussed in Corbel et al. Accordingly, it has been established that the prior art product, which is derived from the same source, i.e. bovine placenta, and share the property of being soluble proteins), demonstrates a reasonable probability that it is either identical or sufficiently similar to the claimed composition that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants.
Merely because a characteristic of a known soluble extracts of bovine placenta is not disclosed in a reference does not make the known product patentable. The new product possesses inherent characteristics which might not be displayed in the tests used the reference. Clear evidence that the product of the cited prior art do not possess a critical characteristic that is possessed by the claimed product, would advance prosecution and might permit allowance of claims to applicants' product.
Thus, the water soluble extracts of bovine placenta taught by Corbel et al. anticipates the claimed composition.
Alternatively, the water soluble extracts of bovine placenta taught by Corbel et al. render the claimed composition obvious.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over JP H06234798 A (published on 8/23/1994; English translation attached).
JP H06234798 A teach a water-soluble protein extracted from bovine placenta and the process of preparing the water-soluble protein extracts involves mincing bovine placenta, homogenization and protein precipitations using ammonium sulfate (Abstract). Thus, the resulting composition of JP H06234798 A comprises soluble proteins from bovine placenta. Thus, JP H06234798 A anticipates the product produced by the method steps of the instant claims.
As discussed above, the product of JP H06234798 A is considered to meet the product produced by the process steps of the instant claims. Furthermore, JP H06234798 A teach conventional method for extracting proteins including centrifugation, salting-out fractionation, gel filtration, dialysis and freeze-drying (p.3, 3rd para.). Thus, it would have been obvious to a person skilled in the art that the water-soluble protein fractions of the bovine placenta would be obtainable from the well-known techniques known in the art, and the product produced by such process would be expected the same as the claimed product.
Regarding claims 4-5, JP H06234798 A do not particularly teach the limitation. However, as the product of JP H06234798 A is considered the same water soluble protein fractions from bovine placenta as the claimed invention, it is expected that the product of JP H06234798 A would inherently contain the same unique proteins as the claimed product including vimentin and actin.
Regarding claim 13 directed to the sterilization step, the product produced by the step would be sterile product, and the step is carried out by filtration. As JP H06234798 A teach gel filtration, ultrafiltration (p.3, 3rd para.), it would have been obvious to a person skilled in the art that the product of JP H06234798 A would be sterile by using the same step of filtration as disclosed in claim 13.
Regarding claim 14, as JP H06234798 A teach freeze-drying method as discussed above, it renders the product of claim 14 obvious.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' composition differs, and if so to what extent, from the aqueous extracts of bovine placenta discussed in Corbel et al. Accordingly, it has been established that the prior art product, which is derived from the same source, i.e. bovine placenta, and share the property of being soluble proteins), demonstrates a reasonable probability that it is either identical or sufficiently similar to the claimed composition that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants.
Merely because a characteristic of a known soluble extracts of bovine placenta is not disclosed in a reference does not make the known product patentable. The new product possesses inherent characteristics which might not be displayed in the tests used the reference. Clear evidence that the product of the cited prior art do not possess a critical characteristic that is possessed by the claimed product, would advance prosecution and might permit allowance of claims to applicants' product.
Thus, JP H06234798 A anticipate or, in alternative, render the claimed product obvious.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbel et al. (supra).
Corbel et al. either anticipate or in alternative, render the subject matter of claims 1-12 and 14-17 obvious (see above).
Regarding claim 13 directed to the sterilized composition comprising soluble protein extracts of cotyledonary placenta, Corbel et al. do not teach the limitation.
However, it would have been obvious to a person skilled in the art to sterilize the soluble protein extracts of Corbel et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the purpose of the extracts taught by Corbel et al. is to test the effect of the soluble extracts of bovine placenta on the growth of fungi (see Abstract), one skilled in the art would recognize that the extracts of Corbel et al. would be sterile to test for the effect.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Relevant Prior Art
The following references are relevant to the claimed subject matter but not cited in the claim rejection above.
Tseng et al. (US 2007/0071828A1) teach a water soluble protein extract from mammalian amniotic membrane, a part of placenta.
Han et al. (WO2012118321; English translation attached): Han et al. teach placenta extract from mammals comprising soluble proteins.
CN105950693A (published 9/21/2016; English translation attached): CN105950693A teach an extract of bovine placenta comprising bioactive polypeptides (Abstract).
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631
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