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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “820” has been used to designate both a female opening for a receiving male protrusion and an open space with not corresponding male protrusion. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
With respect to claim 1, line 4, it is unclear what a copolymer of (1) and (2) is when each of (1) and (2) is a polymer.
With respect to claims 6, 7, and 11, it is unclear what a “random block copolymer” represents because a random copolymer is different from a block copolymer.
With respect to claims 1-5, 8, 9, 13, and 16-18, they are rejected for failing to cure the deficiency of the claim from which they depend.
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 of this title, 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.
Claims 1-5, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Downie (US 2001/0027225) in view of Chang (US 5,258,422).
With respect to claims 1, 3-5, 10, and 12, Downie discloses a polymer composition comprising a polymer such as preferred polyethylene and polypropylene (paragraph 0090) and degradant (abstract), wherein the degradant includes a biodegradant and is present in an amount of 0.01-10 wt % of the polymer composition (paragraph 0042). The biodegradant includes poly-β-hydroxybutyrate and polyesters such as polylactic acid (paragraph 0094). Regarding other polyester biodegradant, Downie incorporates by reference US 5,258,422 (Chang) (paragraph 0091). Chang teaches that biodegradable polymers include polyhydroxybutyrate, polylactic acid, and copolymers of butylene terephthalate and oxalate (col. 11, lines 63-68).
Downie teaches that one or more biodegradants can be used together (paragraph 0091) but
fails to disclose a biodegradant (additive) comprising a blend of (i) polylactic acid and/or polyhydroxyalkanoates in combination with a (ii) polyterephthalate in amounts of (i) and (ii) of 30-70 wt % and 30-70 wt %, respectively.
Even so, when faced with a mixture, one of ordinary skill in the art would be motivated by common sense to select a 1:1 ratio, a ratio that falls within the presently claimed amount, absent evidence of unexpected or surprising results. Case law holds that “[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Therefore, it would have been obvious to one of ordinary skill in the art to utilize any of Downie’s biodegradants including those disclosed by Chang in a 50 wt % and 50 wt % mixture—absent a showing of unexpected or surprising results.
With respect to claim 2, Downie does not require the addition of additional ingredients.
Claims 6-9, 11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Downie (US 2001/0027225) in view of Chang (US 5,258,422) and further in view of Pluquet (US 2020/0216244).
The discussion with respect to Downie and Chang in paragraph 4 above is incorporated here by reference.
With respect to claims 6 and 11, neither Downie nor Chang discloses a poly-terephthalate having the claimed formula.
Pluquet discloses biodegradable resin which include poly adipate-co-terephthalate) and poly(butylene succinate-co-terephthalate) (paragraph 0138) which reads on the formula for a = c = 4 (for butylene) and b = 4 (for succinate) and b = 6 (for adipate). Pluquet does not disclose the relative monomer amounts m and n, however, it is the examiner’s position that the relative amounts determine biodegradable. For instance, if there is too high a molar amount of terephthalate monomer, the poly-terephthalate will not include a sufficient amount of hydrolyzable aliphatic monomers to be biodegradable. Therefore, the poly-terephthalate taught by Pluquet has m ≤ n, i.e., at least 0% difference between m and n.
Given that the combination of Downie and Chang teaches a terephthalate copolymer as the biodegradant, it would have been obvious to one of ordinary skill in the art to utilize a biodegradable polymer having claimed formula for m ≤ n, including m = n = 1 as a suitable biodegradant.
With respect to claims 7-9, and 13-18, Downie discloses polylactic acid as a suitable polyester biodegradant but fails to disclose that the stereoisomer PLLA (poly(L-lactic acid)) is the biodegradant.
Pluquet teaches that the L stereoisomer of provides for crystallinity not present in the stereoisomers (paragraphs 0118 and 0119).
Given that Downie discloses polylactic acid as the biodegradant and further given that Pluquet teaches that PLLA has advantageous crystallinity and melting properties, it would have been obvious to one of ordinary skill in the art to utilize PLLA in combination with the formula of poly-terephthalate as discussed for claims 6 and 11 above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/393,254. Although the claims at issue are not identical, they are not patentably distinct from each other because US appl ‘254 claims a blood pressure cuff comprising tubing made from a composition comprising 90-99.9 a non-degradable polymer such as polyethylene, polypropylene, and/or polyvinylchloride and 0.1-10 wt % of an additive including 30-70 wt % of a first polymer that is PHA or polylactic acid and 30-70 wt % of poly-terephthalate. Although US appl ‘254 claims an article, it would have been obvious to one of ordinary skill in the art to obtain the claimed composition given that US appl ‘254 claims the presently claimed ingredients and amounts thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/490,439. Although the claims at issue are not identical, they are not patentably distinct from each other because US appl ‘439 claims a biodegradable transfer support surface comprising 90-99.9 a non-degradable polymer such as polyethylene, polypropylene, and/or polyvinylchloride and 0.1-10 wt % of an additive including 30-70 wt % of a first polymer that is PHA or polylactic acid and 30-70 wt % of poly-terephthalate. Although US appl ‘439 claims an article, it would have been obvious to one of ordinary skill in the art to obtain the claimed composition given that US appl ‘439 claims the presently claimed ingredients and amounts thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/658,043 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because US appl ‘043 claims a composition comprising a 90-99.9 wt % non-biodegradable polymer including polyethylene, polypropylene, and/or polyvinylchloride 0.1-10 wt % of an additive comprising 30-70 wt % polylactic acid and/or polyhydroxyalkanoates and 30-70 wt % poly-terephthalate. The claims of US appl ‘043 anticipates the presently claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-14 of copending Application No. 18/749,848. Although the claims at issue are not identical, they are not patentably distinct from each other because US appl ‘848 claims a biodegradable disposable made from a composition comprising 90-99.9 a non-degradable polymer such as polyethylene, polypropylene, and/or polyvinylchloride and 0.1-10 wt % of an additive including a first polymer that is PHA or polylactic acid and a poly-terephthalate.
US appl ‘848 fails to disclose the relative amounts of the first and second polymers in the additive.
Even so, when faced with a mixture, one of ordinary skill in the art would be motivated by common sense to select a 1:1 ratio, a ratio that falls within the presently claimed amount, absent evidence of unexpected or surprising results. Case law holds that “[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Therefore, it would have been obvious to one of ordinary skill in the art to prepare a composition comprising an additive include 50 wt % each of the first and second polymers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 9,464,187 discloses a polyvinyl chloride composition comprising 1-50 wt % of a polyhydroxyalkanoate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICKEY NERANGIS whose telephone number is (571)272-2701. The examiner can normally be reached 8:30 am - 5:00 pm EST, Monday - Friday.
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, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Vickey Nerangis/
Primary Examiner, Art Unit 1763
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