DETAILED ACTION
This office action is in response to the communication received August 14, 2026.
The cancellation of claim 25 and addition of claims 35-38 are acknowledged.
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
Newly submitted claims 35-38 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 35-38 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not actually require red blood cells. The subcombination has separate utility such as being a blood product in a filter line made out the plasticizer mixture.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries), such as one requiring invention requiring a container with walls and access port, while the requires specifically red blood cells.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
The previous 35 USC 112(a) rejection of claim 25 is withdrawn in response to amendments to the claim.
Applicant’s arguments regarding Platenkamp are not persuasive. Applicant argues that because Platenkamp’s disclosed range is a maximum of 70% for DEHT with the disclosed minimum of ATBC being 30%, that one of ordinary skill would not have been motivated to arrive at a plasticizer of at least 75% DEHT and up to 25% ATBC as Platenkamp expresses a hierarchy of preferred concentrations of DEHT and ATBC, with the preference being about 60% DEHT and about 40% ATBC. Applicant further argues that Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) do not support obviousness here as the prior art itself identifies more-preferred embodiments that move away from the claimed range.
However, Titanium Metals itself suggests moving away from a preferred embodiment would have been obvious, as the preferred embodiment in Titanium Metals discloses 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium, which therefore would require modifying specific preferences of nickel (0.75% and 0.94%) and molybdenum (0.25% and 0.31%) to be the claimed percentages of 0.8% nickel with 0.3% molybdenum, and the court found such a modification obvious. It is unclear how a preference disclosed as being obviousness to modify in Titanium Metals would not be obvious to modify in this case.
Applicant additionally argues that In re Aller is distinguishable, as In re Aller does not involve a reference that provided preferred concentrations but involves a temperature, and again points out that preferred concentrations move away from the ranges recited in the claims. However, In re Aller is relevant in that it addressed claimed ranges, with a preferred range disclosed in the prior art being found obvious when the claimed ranges or amounts do not overlap with the prior art but are merely close, such as in this case. Additionally, the court, even though the prior art disclosed a preferred range of 50-80 degrees Celsius, found 100 degrees Celsius to be obvious, which again supports that modifying a disclosed preferred range, like that of Platenkamp, would be obvious.
Applicant additionally argues that Warner-Jenkinson is distinguishable from the present situation, as it involved an infringement case where the claim was amended to include ultrafiltration “at a pH from approximately 6.0 to 9.0” to distinguish the claim from the Booth patent, which disclosed a process operating at a pH above 9.0. Applicant additionally states that the Court did not consider whether any pH value was “close enough” to the claimed range for purposes of obviousness, and therefore does not discuss when a non-overlapping range is rendered obvious by a “merely close” prior-art value. However, as is suggested in MPEP 2144.05(I) in support of a section explaining “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close,” Warner-Jenkinson provides support for the case of obviousness when the prior art is merely close as it involves the court finding that a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0.
Applicant’s arguments regarding Sandford are not persuasive. Applicant argues that Sandford does not address the proportions or ratio of DEHT to ATBC within a two-plasticizer mixture. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Platenkamp discloses the use of proportions of DEHT and ATBC and Sandford provides optimizing the amount of DEHT, and therefore both Platenkamp and Sandford, as explained in the analysis below with an explanation of a routine optimization analysis, cover how such claimed ranges are obvious.
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.
Claim(s) 7-9, 12-13, and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Platenkamp et al. (US 2017/0172847).
Regarding claims 7, Platenkamp discloses a flexible blood storage container (see para. 60-61) comprising a pair of walls defining an interior chamber (see para. 80) and at least one access port (see para. 81), said container made of a polymeric material comprising polyvinyl chloride (see para. 80) and a mixture of two extractable plasticizers consisting of di-2-ethylhexyl terephthalate ester (DEHT) and acetyl tr-n-butyl citrate (ATBC) of the plasticizer mixture (see para. 41, 43, 150, DEHT and ATBC).
Platenkamp does not specifically disclose at least 75% of DEHT and up to 25% of ATBC, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp was that the DEHT composition was slightly lower than the maximum disclosed (70%) than the claimed over 75% and the minimum disclosed ATBC composition was slightly higher (30%) than the claimed less than 25%. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of 50-70% DEHT and 30-50% ATBC to be at least 75% DEHT and up to 25% ATBC as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and concentration disclosed in In re Aller. Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 8, teachings of Platenkamp are described above and as mentioned above, Platenkamp does not specifically disclose at least 80% of DEHT and up to 20% of ATBC, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp was that the DEHT composition was slightly lower than the maximum disclosed (70%) than the claimed over 80% and the minimum disclosed ATBC composition was slightly higher (30%) than the claimed less than 20%. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of 50-70% DEHT and 30-50% ATBC to be at least 80% DEHT and up to 20% ATBC as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and disclosed concentration in In re Aller (10% versus 25-70%). Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 9, teachings of Platenkamp are described above and as mentioned above, Platenkamp does not specifically disclose at least 85% of DEHT and up to 15% of ATBC, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp was that the DEHT composition was slightly lower than the maximum disclosed (70%) than the claimed over 80% and the minimum disclosed ATBC composition was slightly higher (30%) than the claimed less than 20%. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of 50-70% DEHT and 30-50% ATBC to be at least 85% DEHT and up to 25% ATBC as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and disclosed concentration in In re Aller (10% versus 25-70%). Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 12, teachings of Platenkamp are described above and Platenkamp further discloses said polymeric material further comprises a stabilizer comprising epoxidized vegetable oil (see para. 103, 115).
Regarding claim 13, teachings of Platenkamp are described above and Platenkamp further discloses the polymeric material further comprises a co-stabilizer comprising a metal stearate (see para. 122, 124-125).
Regarding claim 26, Platenkamp discloses a flexible blood storage container (see para. 60-61) comprising a pair of walls defining an interior chamber (see para. 80) and at least one access port (see para. 81), said container made of a polymeric material comprising polyvinyl chloride (see para. 80) and a mixture of two extractable plasticizers consisting of di-2-ethylhexyl terephthalate ester and acetyl tr-n-butyl citrate of the plasticizer mixture (see para. 41, 43, 150, DEHT and ATBC).
Platenkamp does not specifically disclose the ATBC ratio of the plasticizer mixture is below 0.25, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197), which would result in an ATB ratio of the plasticizer mixture being 0.3-0.5 (30/100 due to 30% and 50/100 due to 50%).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp is that the ATBC ratio disclosed is a little greater than the claimed below 0.25. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of DEHT and ATBC to be an ATBC ratio below 0.25 as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and concentration disclosed in In re Aller. Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 27, Platenkamp discloses a flexible blood storage container (see para. 60-61) comprising a pair of walls defining an interior chamber (see para. 80) and at least one access port (see para. 81), said container made of a polymeric material comprising polyvinyl chloride (see para. 80) and a mixture of two extractable plasticizers consisting of di-2-ethylhexyl terephthalate ester and acetyl tr-n-butyl citrate of the plasticizer mixture (see para. 41, 43, 150, DEHT and ATBC).
Platenkamp does not specifically disclose the ATBC ratio of the plasticizer mixture is approximately 0.21, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197), which would result in an ATBC ratio of the plasticizer mixture being 0.3-0.5 (30/100 due to 30% and 50/100 due to 50%).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp is that the ATBC ratio disclosed is a little greater than the claimed 0.21. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of DEHT and ATBC to be an ATBC ratio of 0.21 as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and concentration disclosed in In re Aller. Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 28, Platenkamp does not explicitly disclose the polymeric material further comprises 100 phr polyvinyl chloride, approximately 43.6 phr DEHT, 11.6 phr ATBC, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate. However, calculations relating the claimed phr to %w/w as well as pointing out the disclosed %w/w ranges of Platenkamp regarding these compositions are outlined below. These are the following calculations:
phr
%w/w = (phr value/sum of phr)*100
Platenkamp disclosed range % w/w
PVC
100
61.9%
45-80% (para. 122)
DEHT and ATBC
55.2
34.2%
20-45% (para. 120)
ESO (epoxidized soybean oil)
6
3.7%
Up to 10% (para. 124-125)
Zinc stearate
0.3
0.2%
1% or less (para. 124-125)
Sum of above phr
161.5
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Platenkamp to have the polymeric material further comprise 100 phr polyvinyl chloride, DEHT and ATBC combined be 55.2 phr, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, as it has been found (see rejection of claim 27) that having the ATBC ratio of the plasticizer mixture be approximately 0.21 would be obvious, having such a ratio would result in having 11.6 phr ATBC ((34.2/100)*161.5*0.21) and 43.6 phr DEHT (55.2-11.6).
Regarding claim 29, Platenkamp discloses a flexible blood storage container (see para. 60-61) comprising a pair of walls defining an interior chamber (see para. 80) and at least one access port (see para. 81), said container made of a polymeric material comprising polyvinyl chloride (see para. 80) and a mixture of two extractable plasticizers consisting of di-2-ethylhexyl terephthalate ester and acetyl tr-n-butyl citrate of the plasticizer mixture (see para. 41, 43, 150, DEHT and ATBC).
Platenkamp does not specifically disclose the ATBC ratio of the plasticizer mixture is approximately 0.18, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197), which would result in an ATBC ratio of the plasticizer mixture being 0.3-0.5 (30/100 due to 30% and 50/100 due to 50%).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp is that the ATBC ratio disclosed is a little greater than the claimed 0.18. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of DEHT and ATBC to be an ATBC ratio of 0.18 as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and concentration disclosed in In re Aller. Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 30, Platenkamp does not explicitly disclose the polymeric material further comprises 100 phr polyvinyl chloride, approximately 45.6 phr DEHT, 10 phr ATBC, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate. However, calculations relating the claimed phr to %w/w as well as pointing out the disclosed %w/w ranges of Platenkamp regarding these compositions are outlined below. These are the following calculations:
phr
%w/w = (phr value/sum of phr)*100
Platenkamp disclosed range % w/w
PVC
100
61.8%
45-80% (para. 122)
DEHT and ATBC
55.6
34.3%
20-45% (para. 120)
ESO (epoxidized soybean oil)
6
3.7%
Up to 10% (para. 124-125)
Zinc stearate
0.3
0.2%
1% or less (para. 124-125)
Sum of above phr
161.9
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Platenkamp to have the polymeric material further comprise 100 phr polyvinyl chloride, DEHT and ATBC combined be 55.6 phr, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, as it has been found (see rejection of claim 29) that having the ATBC ratio of the plasticizer mixture be approximately 0.18 would be obvious, having such a ratio would result in having 10 phr ATBC ((34.3/100)*161.5*0.18) and 45.6 phr DEHT (55.6-10).
Regarding claim 31, Platenkamp discloses a flexible blood storage container (see para. 60-61) comprising a pair of walls defining an interior chamber (see para. 80) and at least one access port (see para. 81), said container made of a polymeric material comprising polyvinyl chloride (see para. 80) and a mixture of two extractable plasticizers consisting of di-2-ethylhexyl terephthalate ester and acetyl tr-n-butyl citrate of the plasticizer mixture (see para. 41, 43, 150, DEHT and ATBC).
Platenkamp does not specifically disclose the ATBC ratio of the plasticizer mixture is approximately 0.15, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197), which would result in an ATBC ratio of the plasticizer mixture being 0.3-0.5 (30/100 due to 30% and 50/100 due to 50%).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). In this case, the only difference between the claims and the composition of the container of Platenkamp is that the ATBC ratio disclosed is a little greater than the claimed 0.15. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have modified the mixture of two extractable plasticizers consisting of DEHT and ATBC to be an ATBC ratio of 0.15 as a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, similar to the range claimed and concentration disclosed in In re Aller. Furthermore, the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties as the material of the container disclosed by Platenkamp, similar to the proportions disclosed in Titanium Metals Corp. of America v. Banner.
Regarding claim 32, Platenkamp does not explicitly disclose the polymeric material further comprises 100 phr polyvinyl chloride, approximately 47 phr DEHT, 8.3 phr ATBC, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate. However, calculations relating the claimed phr to %w/w as well as pointing out the disclosed %w/w ranges of Platenkamp regarding these compositions are outlined below. These are the following calculations:
phr
%w/w = (phr value/sum of phr)*100
Platenkamp disclosed range % w/w
PVC
100
61.9%
45-80% (para. 122)
DEHT and ATBC
55.3
34.2%
20-45% (para. 120)
ESO (epoxidized soybean oil)
6
3.7%
Up to 10% (para. 124-125)
Zinc stearate
0.3
0.2%
1% or less (para. 124-125)
Sum of above phr
161.6
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Platenkamp to have the polymeric material further comprise 100 phr polyvinyl chloride, DEHT and ATBC combined be 55.3 phr, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, as it has been found (see rejection of claim 31) that having the ATBC ratio of the plasticizer mixture be approximately 0.15 would be obvious, having such a ratio would result in having 8.3 phr ATBC ((34.2/100)*161.6*0.15) and 47 phr DEHT (55.3-8.3).
Claim(s) 10-11 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Platenkamp in view of Sandford et al. (US 2014/0276527).
Regarding claim 10, Platenkamp does not specifically teach the mixture of extractable plasticizers consists of at least 90% DEHT and up to 10% ATBC.
Platenkamp discloses the extractable plasticizer being 100% DEHT (see para. 24, 26) in addition to the disclosure of the extractable plasticizer being a mixture of 50-70% of DEHT and 30-50% ATBC (see para. 150, 197). Sandford discloses optimizing the amount of DEHT as it has a hemolysis inhibitory effect (see para. 18, hemolysis inhibitor), thereby suppressing the rupture/destruction of red blood cells and the amount being a result effective variable. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the amount of DEHT and ATBC as it involves only adjusting the composition in a way disclosed to require adjustment. Therefore, it would have been obvious to a one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible blood storage container of Platenkamp by making the amount of DEHT be at least 90% and the amount of ATBC be up to 10% as a matter of routine optimization, therefore optimizing the amount of DEHT based on desired hemolysis inhibitory effect as disclosed by Sandford, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Platenkamp discloses that 100% of DEHT as the plasticizer would work in the composition making up the flexible blood storage container and, consequently, one of ordinary skill in the art would expect that DEHT in amounts between 100% and 70%, amounts both disclosed by Platenkamp with Platenkamp also disclosing a mixture with ATBC, would predictably result in a flexible blood storage container when in a mixture with ATBC.
Regarding claim 11, Platenkamp does not specifically teach the mixture of extractable plasticizers consists of at least 95% DEHT and up to 5% ATBC.
Platenkamp discloses the extractable plasticizer being 100% DEHT (see para. 24, 26) in addition to the disclosure of the extractable plasticizer being a mixture of 50-70% of DEHT and 30-50% ATBC (see para. 150, 197). Sandford discloses optimizing the amount of DEHT as it has a hemolysis inhibitory effect (see para. 18, hemolysis inhibitor), thereby suppressing the rupture/destruction of red blood cells and the amount being a result effective variable. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the amount of DEHT and ATBC as it involves only adjusting the composition in a way disclosed to require adjustment. Therefore, it would have been obvious to a one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible blood storage container of Platenkamp by making the amount of DEHT be at least 95% and the amount of ATBC be up to 5% as a matter of routine optimization, therefore optimizing the amount of DEHT based on desired hemolysis inhibitory effect as disclosed by Sandford, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Platenkamp discloses that 100% of DEHT as the plasticizer would work in the composition making up the flexible blood storage container and, consequently, one of ordinary skill in the art would expect that DEHT in amounts between 100% and 70%, amounts both disclosed by Platenkamp with Platenkamp also disclosing a mixture with ATBC, would predictably result in a flexible blood storage container when in a mixture with ATBC.
Regarding claim 33, Platenkamp does not specifically disclose the mixture of extractable plasticizers consists of DEHT and ATBC wherein the ATBC ratio of the plasticizer mixture is approximately 0.12, as Platenkamp discloses 50-70% of DEHT and 30-50% ATBC (see para. 150, 197), which would result in an ATBC ratio of the plasticizer mixture being 0.3-0.5 (30/100 due to 30% and 50/100 due to 50%). Platenkamp also discloses the extractable plasticizer being 100% DEHT (see para. 24, 26).
Sandford discloses optimizing the amount of DEHT as it has a hemolysis inhibitory effect (see para. 18, hemolysis inhibitor), thereby suppressing the rupture/destruction of red blood cells and the amount being a result effective variable. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the amount of DEHT and relatedly ATBC as it involves only adjusting the composition in a way disclosed to require adjustment. Therefore, it would have been obvious to a one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible blood storage container of Platenkamp by having the ATBC ratio of the plasticizer mixture be approximately 0.12, therefore optimizing the amount of DEHT based on desired hemolysis inhibitory effect as disclosed by Sandford, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Platenkamp discloses that 100% of DEHT as the plasticizer would work in the composition making up the flexible blood storage container and, consequently, one of ordinary skill in the art would expect that DEHT in amounts between 100% and 70%, resulting in ATBC ratios of between 0 and 0.3, amounts both disclosed by Platenkamp with Platenkamp also disclosing a mixture with ATBC, would predictably result in a flexible blood storage container when in a mixture with ATBC.
Regarding claim 34, Platenkamp and Sandford do not explicitly disclose the polymeric material further comprises 100 phr polyvinyl chloride, approximately 49.1 phr DEHT, 6.7 phr ATBC, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate. However, calculations relating the claimed phr to %w/w as well as pointing out the disclosed %w/w ranges of Platenkamp regarding these compositions are outlined below. These are the following calculations:
phr
%w/w = (phr value/sum of phr)*100
Platenkamp disclosed range % w/w
PVC
100
61.7%
45-80% (para. 122)
DEHT and ATBC
55.8
34.4%
20-45% (para. 120)
ESO (epoxidized soybean oil)
6
3.7%
Up to 10% (para. 124-125)
Zinc stearate
0.3
0.2%
1% or less (para. 124-125)
Sum of above phr
162.1
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Platenkamp to have the polymeric material further comprise 100 phr polyvinyl chloride, DEHT and ATBC combined be 55.8 phr, 6 phr epoxidized soybean oil and 0.3 phr zinc stearate since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, as it has been found (see rejection of claim 33) that having the ATBC ratio of the plasticizer mixture be approximately 0.12 would be obvious, having such a ratio would result in having 6.7 phr ATBC ((34.4/100)*162.1*0.12) and 49.1 phr DEHT (55.8-6.7).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
