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 .
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 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 35] The term “low” in claim 35 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The use of term “low” has rendered the size/range of the recited materials indefinite. For purposes of examination, it is interpreted that any dimension of hook or loop material meets the limitations of the claim.
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.
Claims 20-27 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (USPN 5,147,319), in view of Yang et al. (PGPub 2006/0095006).
[Claims 20 and 31] Ishikawa teaches a device (figure 1, item 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 2) (abstract), the device comprising:
a central body portion (figure 1, item 3) in fluid connection with a delivery tube (figure 1, item 11), the medical needle (figure 1, item 2) having a first end and a second end in opposition to one another (figure 1), the first end in fluid connection with the central body portion (figure 1, item 3) and the delivery tube (figure 1, item 11) (figure 1), and the second end of the needle (figure 1, item 2) extending away from the central body portion (figure 1, item 3) to the sharp tip (figure 1), and a line from the first end to the second end of the medical needle (figure 1, item 2) defining a longitudinal axis (figure 1);
a pair of wings (figure 1, items 5a/5b) having an inner region and an outer region (figure 1), the inner region of each one of the pair of wings (figure 1, items 5a/5b) in attachment to (figure 1, via items 4a/4b) the central body portion (figure 1, item 3), the outer region of each one of the pair of wings (figure 1, items 5a/5b) extending away from the central body portion (figure 1, item 3) (figure 1), the pair of wings (figure 1, items 5a/5b) disposed in opposition to one another with the medical needle (figure 1, item 2) positioned therebetween (figures 1 and 2), and the pair of wings (figure 1, items 5a/5b) being selectively positionable from a first position (figure 1) to a second position (figure 3), the first position (figure 1) for placing the medical needle (figure 1, item 2) into a patient and delivering a medicinal fluid (figure 1; column 2, lines 43-46), and the second position (figure 3) for removing the medical needle (figure 1, item 2) from the patient (figure 3; column 2, lines 36-42);
a mechanical fastener (figure 1, items 7/8/9/10a/10b) disposed on at least one of the pair of wings (figure 1, items 5a/5b), the mechanical fastener (figure 1, items 7/8/9/10a/10b) configured to selectively attach the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect the user from the sharp tip of the medical needle (figure 1, item 2) (figures 2, 3, and 4); and
a method comprising:
withdrawing a sharp tip of the medical needle (figure 1, item 2) from a patient (column 1, lines 44-53);
closing the pair of wings (figure 1, items 5a/5b) with the medical needle (figure 1, item 2) positioned therebetween (figures 2 and 3); and
fastening the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect a user from the sharp tip of the medical needle (figure 1, item 2) (figures 2 and 3).
Ishikawa does not specifically disclose that each of the wings is trapezoidal in shape.
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the shape of the wings of Ishikawa, to be trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
[Claims 21, 29, and 30] Ishikawa and Yang teach the limitations of claim 20, upon which claims 21, 29, and 30, depend. In addition, Ishikawa teaches the mechanical fastener (figure 1, items 7/8/9/10a/10b) comprises:
a first mechanical fastener (figure 1, items 7/8) including a lip (figure 1, item 8) extending along at least a portion of the perimeter of at least one of the wings (figure 1, items 5a/5b) (figure 1), and a mating portion (figure 1, item 7) along a perimeter of at least the other one of the wings (figure 1, items 5a/5b) (figure 1), the mating portion (figure 1, item 7) and the lip (figure 1, item 8) configured to engage with one another to selectively attach the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect the user from the sharp tip of the medical needle (figure 1, item 2) (figures 2 and 3; column 2, lines 14-28); and
a second mechanical fastener (figure 1, items 9/10a/10b) different from the first mechanical fastener (figure 1, items 7/8);
wherein at least one of the wings (figure 1, items 5a/5b) forms a groove (groove created by item 7) therein with a size for housing the medical needle (figure 1, item 2) after the pair of wings (figure 1, items 5a/5b) are attached to one another (figures 2 and 3); and
wherein said groove (groove created by item 7) is formed in a single one of the wings (figure 1, items 5a/5b) (figure 4) (the examiner notes the currently recited claim language does not prevent a groove in the opposing wing).
[Claims 22 and 25] Ishikawa and Yang teach the limitations of claim 21, upon which claims 22 and 25 depend. Ishikawa further discloses the second mechanical fastener (figure 1, items 9/10a/10b) includes one of the wings (figure 1, items 5a/5b) forming an orifice (first portion) (figure 2, item 10a) therein, a pin (second portion) (figure 2, item 10b) extending from the other one of the wings (figure 1, items 5a/5b), and the pin (second portion) (figure 2, item 10b) and the orifice (first portion) (figure 2, item 10a) are configured to engage with one another to selectively attach the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect a user from the sharp tip of the medical needle (figure 1, item 2) (figures 2 and 3; column 2, lines 29-33).
[Claims 23 and 24] Ishikawa and Yang teach the limitations of claim 22, upon which claims 23 and 24 depend. Ishikawa also teaches the orifice (figure 2, item 10a) has a diameter (figure 2), the pin (figure 2, item 10b) has a diameter (figure 2), and the diameter of the orifice (figure 2, item 10a) is smaller than the diameter of the pin (figure 2, item 10b) (“The female and male parts 10a,10b couple by elastic deformation.”) (figures 2 and 3; column 2, lines 29-33); wherein the orifice (figure 2, item 10a) has a major axis and a minor axis (figure 2), the pin (figure 2, item 10b) has a diameter (figure 2), the major axis of the orifice (figure 2, item 10a) is longer than the diameter of the pin (figure 2, item 10b) (figures 1 and 2) (the examiner notes the extents of the “major axis” and “minor axis” have not been defined), and the minor axis of the orifice (figure 2, item 10a) is shorter than the diameter of the pin (figure 2, item 10b) (figures 1 and 2) (the examiner notes the extents of the “major axis” and “minor axis” have not been defined).
[Claim 26] Ishikawa and Yang teach the limitations of claim 21, upon which claim 26 depends. In addition, Ishikawa discloses the second mechanical fastener (figure 1, items 9/10a/10b) includes a snap button (figure 2, items 10a/10b) having a male portion (figure 2, item 10b) and a female portion (figure 2, item 10a), the male portion (figure 2, item 10b) of the snap button (figure 2, items 10a/10b) mounted to one of the wings (figure 1, items 5a/5b) (figure 1), the female portion (figure 2, item 10a) of the snap button (figure 2, items 10a/10b) mounted to the other one of the wings (figure 1, items 5a/5b) (figure 1), and the male portion (figure 2, item 10b) and the female portion (figure 2, item 10a) of the snap button (figure 2, items 10a/10b) are configured to engage with one another to selectively attach the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect the user from the sharp tip of the medical needle (figure 1, item 2) (figures 2 and 3; column 2, lines 29-33).
[Claim 27] Ishikawa and Yang teach the limitations of claim 21, upon which claim 27 depends. Ishikawa also teaches discloses the second mechanical fastener (figure 1, items 9/10a/10b) includes one of the wings (figure 1, items 5a/5b) forming an orifice (figure 2, item 10a) therein (figure 1), a pin (figure 2, item 10b) extending from the other one of the wings (figure 1, items 5a/5b) (figure 1), and the pin (figure 2, item 10b) and the orifice (figure 2, item 10a) are configured to engage with one another to selectively attach the pair of wings (figure 1, items 5a/5b) together with the medical needle (figure 1, item 2) positioned therebetween so as to protect a user from the sharp tip of the medical needle (figure 1, item 2) (figures 2 and 3; column 2, lines 29-33).
Ishikawa does not specifically disclose a plurality of orifices or a plurality of pins.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Ishikawa and Yang, to have utilized a plurality of orifices and a plurality of pins, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (USPN 5,147,319), in view of Yang et al. (PGPub 2006/0095006), in further view of Saldwell (PGPub 2006/0167420).
[Claim 28] Ishikawa and Yang teach the limitations of claim 21, upon which claim 28 depends. Ishikawa and Yang do not specifically disclose a second mechanical fastener comprising an adhesive material on at least one of the wings which is configured to engage with the other wing so as to protect a user from a sharp tip of a needle.
However, Saldwell teaches a device (figure 1) for protecting a user from a sharp tip of a needle (figure 1, item 6), wherein the device comprises a pair of wings (figure 1, items 1/2), as well as a mechanical fastener comprising an adhesive material (“adhesive means”) for engaging said wings (figure 1, items 1/2) for enclosing a sharp tip of a needle (figure 1, item 6) (figure 7a; paragraph [0065]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Ishikawa and Yang, to have utilized a second mechanical fastener comprising an adhesive material, as taught by Saldwell, in order to provide an alternative, yet known means, of providing a fastener for engaging the pair of wings to protect a user from the sharp tip of the needle.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Sasso (PGPub 2002/0111581), in view of Yang et al. (PGPub 2006/0095006).
[Claim 32] Sasso teaches a device (figure 1, item 20) for protecting a user from a sharp tip of a medical needle (paragraph [0001]), the device comprising:
a central body portion (figure 1, item 26) in fluid connection with a delivery tube (figure 1, item 58) (paragraph [0030]);
a medical needle (figure 1, item 22) having a first end (figure 2, item 22d) and a second end (figure 1, item 22e) in opposition to one another (figure 1), the first end (figure 2, item 22d) in fluid connection with the central body portion (figure 1, item 26) and the delivery tube (figure 1, item 58) (paragraph [0030]), and the second end (figure 1, item 22e) of the needle (figure 1, item 22) extending away from the central body portion (figure 1, item 26) to a sharp tip (figure 1), and a line from the first end (figure 2, item 22d) to the second end (figure 1, item 22e) of the medical needle (figure 1, item 22) defining a longitudinal axis (figure 2);
a pair of wings (figure 1, items 28/30) having an inner region (figure 1, near 32 and extending in a radially distal direction) and an outer region (figure 1, radially distal from items 48/54), the inner region (figure 1, near 32 and extending in a radially distal direction) of each one of the pair of wings (figure 1, items 28/30) in attachment to the central body portion (figure 1, item 26) (figure 1), the outer region (figure 1, radially distal from items 48/54) of each one of the pair of wings (figure 1, items 28/30) extending away from the central body portion (figure 1, item 26) (figure 1), the pair of wings (figure 1, items 28/30) disposed in opposition to one another with the medical needle (figure 1, item 22) positioned therebetween (figure 1), and the pair of wings (figure 1, items 28/30) being selectively positionable from a first position (figure 1) to a second position (figure 2), the first position (figure 1) for placing the medical needle (figure 1, item 22) into a patient and delivering a medicinal fluid, and the second position (figure 2) for removing the medical needle (figure 1, item 22) from the patient (figures 1 and 2); and
a mechanical fastener (figure 1, items 38/42/44/46/48/50/52/54) disposed on at least one of the pair of wings (figure 1, items 28/30) (paragraph [0029]), the mechanical fastener (figure 1, items 38/42/44/46/48/50/52/54) configured to selectively attach the pair of wings (figure 1, items 28/30) together with the medical needle (figure 1, item 22) positioned therebetween so as to protect the user from the sharp tip of the medical needle (figure 1, item 22) (figure 2; paragraph [0029]).
Sasso does not specifically disclose that the pair of wings are trapezoidal.
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the shape of the wings of Sasso, to be trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 33-36, 38, and 39, are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (PGPub 2002/0111581), in view of Yang et al. (PGPub 2006/0095006), in further view of Saldwell (PGPub 2006/0167420).
[Claims 33-35] Sasso and Yang teach the limitations of claim 32, upon which claims 33-35 depend. Sasso and Yang do not specifically disclose a mechanical fastener comprising a hook-and-loop fastening system.
However, Saldwell teaches a device for protecting a user from a sharp tip of a medical needle (paragraphs [0014]-[0021]), the device comprising:
a central body (figure 1, item 5) in fluid connection with a delivery tube (figure 1, item 7);
a medical needle (figure 3a, item 6) including:
a first end in fluid connection with the delivery tube (figures 1 and 2b);
a second end distal from the central body (figure 1, item 5), the second end including the sharp tip (figure 3b);
a pair of wings (figure 1, items 1 and 2) extending from, and attached at one end to, the central body (figure 1, item 5), the pair of wings being selectively positionable from an open position (figure 2b), in which the wings leave the needle (figure 3a, item 6) exposed so as to permit the medical needle to be placed into a patient (figure 4), to a closed position (figure 2a) in which the pair of wings are folded over the needle (figure 3a, item 6); and
a hook-and-loop fastening system (“Velcro tape”) including a low profile (see 112b rejection interpretation above) hook material disposed on one of the pair of wings (figures 7a and 7b) and a low profile (see 112b rejection interpretation above) loop material disposed on the other wing of the pair of wings (figures 7a and 7b), the hook-and-loop fastening system configured to selectively attach each inner surface of the pair of wings together to one another in the closed position with the medical needle positioned therebetween (figures 7a and 7b; paragraphs [0029], [0065]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the fastener taught by Sasso, with the use of a hook-and-loop fastener, as taught by Saldell, as both structures could be considered mechanical fasteners, wherein substituting one structure for the other would result in the same predictable result of securing one wing to the other wing.
[Claim 36] Sasso, Yang, and Saldwell, teach the limitations of claim 33, upon which claim 36 depends. Although disclosing the use of a hook-and-loop fastening system to secure the pair of wings together (requiring a hook material on one wing and a loop material on the other wing), Saldell does not specifically disclose a hook material on each wing of the pair of wings and a loop material on each wing of the pair of wings.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize more than one set of hook-and-loop components, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to reverse the orientation of said hook and loop materials, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
[Claim 38] Sasso, Yang, and Saldwell, teach the limitations of claim 33, upon which claim 38 depends. In addition, Sasso teaches the medical needle (figure 1, item 22) is perpendicular to a main axis of the central body portion (figure 1, item 26) (figure 1).
[Claim 39] Sasso, Yang, and Saldwell, teach the limitations of claim 33, upon which claim 39 depends. Sasso further discloses the wings (figure 1, items 28/30) are made from semi-rigid material (paragraph [0027]).
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 20, 29, 30, and 32, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 9 of U.S. Patent No. 8,500,703, in view of Yang et al. (PGPub 2006/0095006). Claims 1, 8, and 9, of U.S. Patent No. 8,500,703 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1, 8, and 9, of USPN 8,500,703, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-14 of U.S. Patent No. 9,308,322, in view of Yang et al. (PGPub 2006/0095006). Claims 1-7 and 11-14 of U.S. Patent No. 9,308,322 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1-7 and 11-14, of USPN 9,308,322, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20, 21, and 31-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,350,350, in view of Yang et al. (PGPub 2006/0095006). Claims 1-8 of U.S. Patent No. 10,350,350 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1-8 of USPN 10,350,350, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9,808,576, in view of Yang et al. (PGPub 2006/0095006). Claims 2 of U.S. Patent No. 9,808,576 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claim 2 of USPN 9,808,576, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20, 29, 30, and 32, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 12, of U.S. Patent No. 10,441,715, in view of Yang et al. (PGPub 2006/0095006). Claims 1, 10, and 12, of U.S. Patent No. 10,441,715 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1, 10, and 12, of USPN 10,441,715, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20, 29, 31, and 32-34, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 15, 16, and 20, of U.S. Patent No. 11,878,144, in view of Yang et al. (PGPub 2006/0095006). Claims 1, 8, 15, 16, and 20, of U.S. Patent No. 11,878,144 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1, 8, 15, 16, and 20, of USPN 11,878,144, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20, 29, 30, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 9, of U.S. Patent No. 8,961,476, in view of Yang et al. (PGPub 2006/0095006). Claims 1, 8, and 9, of U.S. Patent No. 8,961,476 teaches all the limitations of claims 20 and 32 of the instant application, but does not explicitly disclose wings which are “trapezoidal.”
However, Yang teaches a device (figure 1) for protecting a user from a sharp tip of a medical needle (figure 1, item 23) comprising a pair of trapezoidal wings (figure 1, item 11).
In addition to the claimed limitations of claims 1, 8, and 9, of USPN 8,961,476, it would have been obvious to one of ordinary skill in that art, before the effective filing date of the invention, to have utilized wings which are trapezoidal, as taught by Yang, as applicant’s specification places no criticality on any particular shape. Further, it has been held that a change in shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20, 29, 30, 32-37, and 39, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 15, 16, 17, 19, and 20, of copending Application No. 18/766496 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited copending application claims. For example, all of the elements of claim 20 of the instant application can be found in claim 1 of the copending application. The difference between claim 20 of the instant application and claim 1 of the copending application lies in the fact that the copending application claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the copending application is in effect a “species” of the "generic” invention of claim 20 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 20 of the instant application is anticipated by claim 1 of the copending application, it is not patentably distinct from claim 1 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JASON E FLICK/Primary Examiner, Art Unit 3783 06/12/2026
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