CTNF 17/768,360 CTNF 85052 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 16-25, 28, and 29 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. Regarding claim 16: The scope of the claimed invention is unclear with regards to the melt volume flow rate (MVR) of claimed block copolymer P1. As currently written, the claimed composition may comprise 100 wt% of block copolymer P1, which has a MVR (200 °C, 5kg) in the range of 30 to 40 cm 3 /min. Note, however, that claim 16 also requires that overall composition has a MVR (200 °C, 5kg) of 24 to 40 cm 3 /10 min-i.e., 2.4 to 4.0 cm 3 /min. It is unclear how the claimed composition can comprise 100 wt% of block copolymer P1 having a MVR in the range of 30 to 40 cm 3 /min, when the overall composition is required to have a MVR under the same conditions that is at least 7.5 times less than the MVR of block copolymer P1. Furthermore, note that applicant’s inventive example 15 (see specification tables 1 and 2) is reported to contain 100 wt% of the polymer P1 used in the other examples is reported to have a MVR of 34.1 cm 3 /10 min. It has been held that a claim, although clear on its face, may also be indefinite when a conflict or inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty; see In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970) (MPEP § 2173.03). Given the apparent inconsistency between the units of MVR for the composition and block copolymer P1 in combination with the use of the unit cm3/10 min for inventive polymer P1 in the example 15 of the specification, it is unclear whether the claimed invention is intended to require that MVR of P1 is intended to be 30 to 40 cm 3 /min, as currently recited, or if this was an error intended to be 30 to 40 cm 3 /10 min, as used in the inventive example. Claims 17-25 depend from claim 16 and do not correct this deficiency. The claims are therefore indefinite per the same rationale as claim 16. Regarding claim 23: Claim 23 depends from claim 16, and states that the composition comprises 1 to 10 wt% general purpose polystyrene. The phrase “general purpose” renders the claim indefinite, as it is unclear whether this is intended to implicitly require that the polystyrene must have certain properties and/or characteristics, or if the claim reads on the use of any polystyrene. Regarding claim 28: Claim 28 recites an invention which is a method of preparing a molding; however, the claim does not recite any active, positive steps delimiting how the method is performed. The scope of the claim is therefore indefinite, as it is unclear what process step(s) are intended to be covered by the claimed invention. Claim 29 depends from claim 28 and does not correct this deficiency. The claim is therefore indefinite per the same rationale as claim 28. 07-30-03-h AIA Claim Interpretation As discussed earlier in this Action, it is unclear whether the units for the MVR of claimed component P1 are intended to be cm 3 /min or cm 3 /10 min. Given that the composition can contain 100 wt% of the polymer P1 and the use of the unit cm3/10 min in the examples of the specification, the claim has been interpreted to require that units for the MVR of polymer P1 are cm 3 /10 min. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim (s) 16-22 and 24 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Bender et al, EP0612672 . The examiner notes that a machine translation of Bender was used to prepare this Action. Bender discloses the production of a monovinyl aromatic/diene block copolymer having a MVR in the range of 10 to 70 mL/10 min (i.e., 10 to 70 cm 3 /10 min) which is used in the production of films (abstract; page 2: lines 39-40). Example 2 of Bender discloses a diblock copolymer comprising a polystyrene block, corresponding to the claimed hard block (A1) comprising 100% vinyl aromatic monomer (for claim 16), and a polybutadiene block, corresponding to the claimed soft block (B1) comprising 100% diene (for claim 16). Said diblock copolymer is reported to have a melt volume flow rate (MVR) of 32; note that this value falls within the both the range for MVR of the overall composition (for claim 16) and the range for the MVR of the block copolymer P1 (for claim 16). The composition of Example 2 includes a combined total of 4.85 wt% various additives; the composition of Example 2 therefore comprises 95.15 wt% of the block copolymer (for claims 16, 17). Regarding claimed component P2: As written, the claimed invention may comprise 0 wt% of block copolymer P2. The prior art composition therefore corresponds to the claimed invention wherein the amount of block copolymer P2 is 0 wt% (for claims 16, 17). Regarding claimed component P3: As written, the claimed invention may comprise 0 wt% of block copolymer P3. The prior art composition therefore corresponds to the claimed invention wherein the amount of block copolymer P3 is 0 wt% (for claims 16, 17). Regarding claimed component C: The composition of Bender’s Example 3 is reported to comprise 0.1 wt% stearamide, corresponding to the claimed demolding agent C (for claims 16, 17, 24). Regarding claimed component D: As noted above, the composition of Example 2 comprises a combined total of 4.85 wt% additives. Subtracting the content of stearamide, it is therefore calculated that the remaining additives are present in an amount of 4.75 wt%, corresponding to claimed additives D (for claims 16, 17). Regarding the claimed provisos: As noted discussed above, the prior art composition corresponds to the claimed invention comprising 95.15 wt% of P1, 0 wt% P2, and 0 wt% P3. The sum of these numbers is therefore 95.15 wt%, satisfying the first proviso (for claims 16). Furthermore, as the amount of P1 is 95.15 wt%, the second proviso is not required (for claim 16). Regarding claim 19: “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…" as that required with respect to product-by-process claims. In re Fitzgerald , 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (MPEP § 2112). Bender is silent regarding the glass transition of the blocks of the prior art block copolymer; however, it is reasonably expected that the claimed properties are met by the prior art. As noted above, the prior art block copolymer comprises a polystyrene block and a polybutadiene block; these are the same monomers as disclosed by applicant for the use in the claimed hard and soft blocks (see specification page 9: lines 27-31). As the prior art blocks are made from the same monomers as the claimed hard and soft blocks, it is reasonably expected that their properties would inherently be the same as those of the claimed invention. The burden is therefore shifted to the applicant to provide evidence that the prior art block copolymer would not satisfy the required glass transition temperatures. Regarding claims 20-22: Claims 20 to 22 depend from claim 16 and recite further limitations regarding either component P2 or P3. Note, however, that the claims do not contain any language requiring either of these components to be present. The prior art composition therefore corresponds to the claimed invention wherein the amounts of P2 (for claims 20, 21) and P3 (for claim 22) are 0 wt% . 07-15 AIA Claim (s) 26 and 28 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Hasselbring, US4331048 . Hasselbring discloses the production of a composition comprising a blend of a monovinyl aromatic/conjugated diene block copolymer and a polybutene, wherein the prior art composition can be used in the production of molded articles, corresponding to the claimed molding (for claims 26, 28) used in the medical field, corresponding to the claimed medical device (for claims 26, 28) (abstract; Column 2: lines 3-11). Hasselbring discloses the use of block copolymers comprising polystyrene block(s), corresponding to the claimed block A1 (for claims 26, 28) and polybutadiene block(s), corresponding to claimed block B1 (for claims 26, 28) (Column 2: lines 35-43). Example 2 (Table 1) discloses a composition comprising 98 wt% of a styrene/butadiene block copolymer comprising 75 wt% styrene block and 25 wt% polybutadiene block, corresponding to claimed polymer P1 (for claim 26, 28), and 2 wt% polybutene, corresponding to the claimed thermoplastic P3 (for claim 26, 28). Regarding claimed component P2: As written, the claimed invention may comprise 0 wt% of block copolymer P2. The prior art composition therefore corresponds to the claimed invention wherein the amount of block copolymer P2 is 0 wt% (for claims 26, 28). Regarding claimed component C: As written, the claimed invention may comprise 0 wt% of block component C. The prior art composition therefore corresponds to the claimed invention wherein the amount component C is 0 wt% (for claims 26, 28). Regarding claimed component D: As written, the claimed invention may comprise 0 wt% of block component D. The prior art composition therefore corresponds to the claimed invention wherein the amount component D is 0 wt% (for claims 26, 28). Regarding the claimed provisos: As noted discussed above, the prior art composition corresponds to the claimed invention comprising 98 wt% of P1 and 2 wt% P3. The sum of these numbers is therefore 100 wt%, satisfying the first proviso (for claims 26, 28). Furthermore, as the amount of P1 is 98 wt%, the second proviso is not required (for claim 16) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 18 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bender et al, EP0612672 . As discussed earlier in this Action, Bender discloses a monovinyl aromatic/diene block copolymer which is used in the production of films. The prior art composition is process via extrusion-i.e., a melt blending technique (for claim 25) (page 3: lines 14-15). Bender teaches that the prior art block copolymer may be a S-B-S block copolymer, wherein S is a polystyrene block and B is a polybutadiene block (page: lines). Bender further teaches that the prior art block copolymer is characterized by a diene content in the range of 30 to 50 wt% (page 2: lines 30-32), overlapping the claimed range. Bender does not specifically disclose the production of a block copolymer having a diene content in the range of 20 to 30 wt% or compounding at a temperature of 180 to 280 °C. Regarding the claimed temperature: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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"; see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05(II)(A)). As discussed above, the prior art teaches a process wherein the same components are combined with one another in an extruder. It is known in the art that temperature is a result effective variable, with the viscosity of the polymer melt-and by extension its processability through the device, changing as temperature increases/decreases. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to vary the temperature through routine experimentation in order to ensure the composition is melted and to adjust its viscosity for processing. Regarding the diene content: It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed in the prior art, a prima facie case of obviousness exists; see 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). The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages; see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (" (MPEP § 2144.05). The prior art range for diene content overlaps the claimed range. Barring a showing of evidence, demonstrating unexpected results, it therefore would have been obvious to one of ordinary skill in the art to prepare a block copolymer having the claimed diene content in view of the teachings of Bender . Allowable Subject Matter 07-43-02 AIA Claim 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. 12-151-08 AIA 07-43 12-51-08 Claim s 27 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: The following references are relevant to the patentability of the claimed invention . Bender et al, EP0612672: As discussed earlier in this Action, Bender discloses the production of a composition comprising a monovinyl aromatic/diene block copolymer having a MVR in the range of 10 to 70 mL/10 min (i.e., 10 to 70 cm 3 /10 min), and the use of said composition for the production of of films. Further note that Bender specifies that said film is intended for use in food packaging applications (page 2: lines 14-15). Bender does not teach the addition of a polystyrene to the composition of EP0612672 (for claim 23), nor does it teach the use of the prior art composition in the production of medical devices (for claims 28, 29). Hasselbring, US4331048: As discussed above, Hasselbring discloses the production of a composition comprising a blend of a monvinyl aromatic/conjugated diene block copolymer and a polybutene, wherein the prior art composition can be used in the production of molded articles used in the medical field. Note that Hasselbring does not explicitly disclose the MVR of the prior art block copolymer, nor is there any data that could be used to estimate the MVR. Hasselbring therefore does not teach a composition having the MVR properties required by the composition of claim 23. Furthermore, Hasselbring does not teach that the prior art composition is suitable for use in the production of a drip chamber. The cited references do not teach all of the claimed limitations, nor has a reference been found that would have provided motivation to alter the teachings of either Bender or Hasselbring to satisfy the limitations as claimed. The claims are therefore allowable. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY S LENIHAN whose telephone number is (571)270-5452. The examiner can normally be reached Mon.-Fri. 5:30-2:00PM. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765 Application/Control Number: 17/768,360 Page 2 Art Unit: 1765 Application/Control Number: 17/768,360 Page 3 Art Unit: 1765 Application/Control Number: 17/768,360 Page 4 Art Unit: 1765 Application/Control Number: 17/768,360 Page 6 Art Unit: 1765 Application/Control Number: 17/768,360 Page 7 Art Unit: 1765 Application/Control Number: 17/768,360 Page 8 Art Unit: 1765 Application/Control Number: 17/768,360 Page 10 Art Unit: 1765 Application/Control Number: 17/768,360 Page 11 Art Unit: 1765 Application/Control Number: 17/768,360 Page 12 Art Unit: 1765 Application/Control Number: 17/768,360 Page 13 Art Unit: 1765