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 .
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, 4 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11602445B2 in view of Laghi (2011/0029096A1).
It has been held that a species anticipates a genus and the prior filed patent
anticipates each and every aspect of the instant claim except
“a closed bottom end incorporating a sweat port having a one-way valve at a distal tip attached to a cylindrically symmetrical buttress;
and at least one channel in the distal end of the liner which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner”.
Laghi teaches a closed bottom end (1) incorporating a sweat port 4 having a one-way valve [0012: duckbill one way valve] at a distal tip attached to a cylindrically symmetrical buttress 6;
and at least one channel (through inside of 6) in the distal end of the liner 1 which penetrates the inner layer of thermoplastic material and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner. [1101]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sweat port of Laghi in the liner because this prevents air breaches in the liner and eliminates sweat [0011].
While silicone is not a thermoplastic material, the instant claims refer to silicone as a thermoplastic material (see claim 4) and therefore based on the applicant’s own language, silicone meets the definition of a thermoplastic material in the claim.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11602445B2 in view of Laghi (2011/0029096A1).
It has been held that a species anticipates a genus and the prior filed patent
anticipates each and every aspect of the instant claim except
“a closed bottom end incorporating a sweat port having a one-way valve at a distal tip attached to a cylindrically symmetrical buttress;
and at least one channel in the distal end of the liner which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner”.
Laghi teaches a closed bottom end (1) incorporating a sweat port 4 having a one-way valve [0012: duckbill one way valve] at a distal tip attached to a cylindrically symmetrical buttress 6;
and at least one channel (through inside of 6) in the distal end of the liner 1 which penetrates the inner layer of thermoplastic material and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner. [1101]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sweat port of Laghi in the liner because this prevents air breaches in the liner and eliminates sweat [0011].
While silicone is not a thermoplastic material, the instant claims refer to silicone as a thermoplastic material (see claim 4) and therefore based on the applicant’s own language, silicone meets the definition of a thermoplastic material in the claim in as much as that of the applicant’s own invention.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11602445B2 in view of Laghi (2011/0029096A1).
It has been held that a species anticipates a genus and the prior filed patent
anticipates each and every aspect of the instant claim except
“a closed bottom end incorporating a sweat port having a one-way valve at a distal tip attached to a cylindrically symmetrical buttress;
and at least one channel in the distal end of the liner which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner”.
Laghi teaches a closed bottom end (1) incorporating a sweat port 4 having a one-way valve [0012: duckbill one way valve] at a distal tip attached to a cylindrically symmetrical buttress 6;
and at least one channel (through inside of 6) in the distal end of the liner 1 which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner. [1101]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sweat port of Laghi in the liner because this prevents air breaches in the liner and eliminates sweat [0011].
While silicone is not a thermoplastic material, the instant claims refer to silicone as a thermoplastic material (see claim 4) and therefore based on the applicant’s own language, silicone meets the definition of a thermoplastic material in the claim.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11602445B2 in view of Laghi (2011/0029096A1).
It has been held that a species anticipates a genus and the prior filed patent
anticipates each and every aspect of the instant claim except
“a closed bottom end incorporating a sweat port having a one-way valve at a distal tip attached to a cylindrically symmetrical buttress;
and at least one channel in the distal end of the liner which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner”.
Laghi teaches a closed bottom end (1) incorporating a sweat port 4 having a one-way valve [0012: duckbill one way valve] at a distal tip attached to a cylindrically symmetrical buttress 6;
and at least one channel (through inside of 6) in the distal end of the liner 1 which penetrates the inner layer of thermoplastic material and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner. [1101]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sweat port of Laghi in the liner because this prevents air breaches in the liner and eliminates sweat [0011].
While silicone is not a thermoplastic material, the instant claims refer to silicone as a thermoplastic material (see claim 4) and therefore based on the applicant’s own language, silicone meets the definition of a thermoplastic material in the claim and is by its nature an elastomer gel.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11602445B2 in view of Laghi (2011/0029096A1).
It has been held that a species anticipates a genus and the prior filed patent
anticipates each and every aspect of the instant claim except
“a closed bottom end incorporating a sweat port having a one-way valve at a distal tip attached to a cylindrically symmetrical buttress;
and at least one channel in the distal end of the liner which penetrates the inner layer of thermoplastic material (according to the instant claims and disclosure of the instant invention, the applicant considers silicone as a thermoplastic material) and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner” and “the elastomer gel is a styrene block copolymer”.
Laghi teaches a closed bottom end (1) incorporating a sweat port 4 having a one-way valve [0012: duckbill one way valve] at a distal tip attached to a cylindrically symmetrical buttress 6;
and at least one channel (through inside of 6) in the distal end of the liner 1 which penetrates the inner layer of thermoplastic material and the cylindrically symmetrical buttress such that the one-way valve of the sweat port can conduct air, gases, and perspiration from the inner layer of thermoplastic material to the exterior of the prosthetic liner. [1101]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sweat port of Laghi in the liner because this prevents air breaches in the liner and eliminates sweat [0011].
Laghi further teaches wherein the elastomer gel is a styrene block copolymer. [0020: elastomeric material may include styrene block copolymers]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the elastomeric material of Laghi in place of the silicone liner material because the material acts as a distribution polymer [0020]
While silicone is not a thermoplastic material, the instant claims refer to silicone as a thermoplastic material (see claim 4) and therefore based on the applicant’s own language, silicone meets the definition of a thermoplastic material in the claim and is by its nature an elastomer gel.
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.
Claim(s) 3-4 is/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.
In regard to claim 3, “the silicone thickness” lacks proper antecedent basis.
In regard to claim 4, the claim states that “the thermoplastic material is silicone”. Silicone is not a thermoplastic material. Thermoplastics soften when heated and harden upon cooling by definition. The instant disclosure does not provide any further clarification and appears to distinguish between the thermoplastic materials such as styrene block copolymers and silicones.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774