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 .
Response to Arguments
Applicant’s arguments, filed February 26, 2025, with respect to the rejection(s) of claims 1-20 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of U.S. Patent No. 2,888,015 to Hunt in view of U.S. Publication No. 201/0207079 to Creaturo.
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 19 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 19 recites the limitation "the second color" in line two. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, the second color will be interpreted as a second color.
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.
Claims 1-6, 8-11, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 2,888,015 to Hunt (Hunt) in view of U.S. Publication No. 201/0207079 to Creaturo (Creaturo).
Regarding claim 1, Hunt teaches a barrel (10; Col. 2 ln. 1-4) including a plurality of barrel markings (see fig. 7-11), wherein the plurality of barrel markings includes at least 1) numeric markings (33; Col 2 ln. 50-53) and 2)a plurality of fill indicators (34, 35, 36, 37) printed on the barrel (Col. 1 ln. 68-72; Col. 2 ln. 55-62), and wherein the plurality of fill indicators defines open space enclosed by the plurality of fill indicators (Col. 2 ln. 60-62); and a seal (17; Col. 2 ln. 27-34) slidably positioned within the barrel for moving a delivery agent, wherein the seal is visible within at least one of the plurality of fill indicators (Col. 3 ln. 5-15), but fails to explicitly teach the seal is colored.
Creaturo teaches the use of a color seal (404; 0052).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the colored seal of Creaturo with the device of Hunt in order to enhance the visual identification through the barrel of the dosage and assist in visual accuracy.
Regarding claim 2, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches a plunger (Col. 2 ln. 28-30) for moving the colored seal within the barrel to insert and remove the delivery agent (see fig. 7-11), but fails to explicitly disclose wherein the colored seal is connected to a plunger.
Creaturo teaches the use of a plunger rod (401) and a colored seal (404; 0052).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the configuration of the plunger rod and seal of Creaturo with the device of Hunt in order to ensure more precise medicament delivery.
Regarding claim 3, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches wherein the barrel is transparent or semi-transparent (Col. 3 ln. 5-10), and Creaturo teaches wherein the colored seal is fluorescent (0052).
Regarding claim 4, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches wherein the plurality of barrel markings further include line markings (32), and wherein each of the numeric markings are associated with one of the plurality of fill indicators (Col. 2 ln. 50-62).
Regarding claim 5, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches wherein the plurality of fill indicators are one or more of a square, triangle, oval, star, octagon, hexagon, and rectangle (see fig. 8, 10, 11).
Regarding claim 6, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches wherein the colored seal system is a syringe (Col. 1 ln. 64-66), and wherein the delivery agent is a medication (insulin- Col. 1 ln. 65-72).
Regarding claim 8, Hunt in view of Creaturo teach the claim limitation of claim 1, where Creaturo teaches wherein a size of a front bevel (as shown in Annotated Fig. 4C-1) of the colored seal within the barrel corresponds to a size of the plurality of fill indicators (as shown in Annotated Fig. 4C-1- where it appears that the size of the front bevel and the size of the plurality of fill indicators compare closely, and thus “correspond” to one another).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the wherein a size of a front bevel of the colored seal within the barrel corresponds to a size of the plurality of fill indicators in order to increase accuracy in medicament delivery.
PNG
media_image1.png
440
340
media_image1.png
Greyscale
Regarding claim 9, Hunt in view of Creaturo teach the claim limitation of claim 1, where Hunt teaches wherein the plurality of fill indicators represents a pair of lines extending around a circumference of the barrel (see fig. 8 and 9).
Regarding claim 10, Hunt teaches a syringe (Col.1 ln. 64-66), comprising: a barrel (10; Col. 2 ln. 1-4) including a delivery end (31; Col. 2 ln. 50-52) for a needle or outlet, the barrel further includes a plurality of barrel markings printed on the barrel (Col. 1 ln. 68-72), wherein the plurality of barrel markings includes at least 1) numeric measurements associated with each of a plurality of fill indicators (33; Col. 2 ln. 50-53), and 2) wherein the plurality of fill indicators (34, 35, 36, 37) defines open space enclosed by the plurality of fill indicators (Col.1 ln. 68-72, Col. 2 ln. 55-62); and a seal (17; Col. 2 ln 27-34) slidably positioned within the barrel for moving a delivery agent within the barrel (Col. 2 ln. 27-36) wherein the colored seal is visible within at least one of the plurality of fill indicators (Col. 3 ln. 5-10), but fails to explicitly teach a colored seal, where the colored seal is brightly colored.
Creaturo teaches the use of a colored seal (404; 0052) where the color seal is brightly colored (0052).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the brightly colored seal of Creaturo with the device of Hunt in order to enhance the visual identification through the barrel of the dosage and assist in visual accuracy.
Regarding claim 11, Hunt in view of Creaturo teach the claim limitation of claim 10, where Hunt teaches wherein the barrel is transparent or semi-transparent (Col. 3 ln. 5-10), and Creaturo teaches wherein the colored seal is fluorescent (0052).
Regarding claim 13, Hunt in view of Creaturo teach the claim limitation of claim 10, where Hunt teaches wherein the plurality of fill indicators are one or more of a square, triangle, oval, star, octagon, hexagon, and rectangle (see fig. 8, 10, 11).
Regarding claim 14, Hunt in view of Creaturo teach the claim limitation of claim 10, where Hunt teaches wherein the plurality of barrel markings further include line markings (32; Col. 2 ln. 50-55).
Regarding claim 15, Hunt teaches a barrel (10; Col. 2 ln. 1-4) including a delivery end for a needle or outlet (31; Col. 2 ln. 50-52) and 2) a plunger end (near 18; Col. 2 ln. 27-36) opposite the delivery end, the barrel further includes a plurality of barrel markings printed on the barrel (Col. 1 ln. 68-72), wherein the plurality of barrel markings includes at least numeric measurements (33; Col. 2 ln. 50-53), associated with each of a plurality of fill indicators (34, 35, 36, 37) and wherein the plurality of fill indicators defines open space closed by the plurality of fill indicators (Col.1 ln. 68-72, Col. 2 ln. 55-62);a seal slidably (17; Col. 2 ln 27-34) secured within the barrel for communicating a delivery agent within the barrel (Col. 2 ln. 27-36), and wherein the seal is visible within at least one of the plurality of fill indicators when aligned (Col. 3 ln. 5-10); and a plunger (17/18; Col. 2 ln. 26-36) connected to the colored seal for receiving a user force to add or eject the delivery agent from the barrel (Col. 2 ln. 26-36), but fails to explicitly teach but fails to disclose a colored seal, the colored seal is connected to a plunger, and the color seal is fluorescent.
Creaturo teaches the use of a plunger rod (401) and a colored seal (404; 0052), and wherein the color seal is fluorescent (0052).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the configuration of the plunger rod and fluorescent seal of Creaturo with the device of Hunt in order to ensure more precise medicament delivery.
Regarding claim 16, Hunt in view of Creaturo teach the claim limitation of claim 15, where Hunt teaches wherein the barrel markings further include line markings (32; Col. 2 ln. 50-62), and wherein the barrel markings are printed on the barrel (Col. 1 ln. 68-72, Col. 2 ln. 68-72).
Regarding claim 17, Hunt in view of Creaturo teach the claim limitation of claim 15, where Hunt teaches wherein the plurality of fill indicators is utilized to fill the barrel to a desired level with the delivery agent (Col. 2 ln. 40-72).
Regarding claim 18, Hunt in view of Creaturo teach the claim limitation of claim 15, where Hunt teaches wherein the barrel is transparent or semi-transparent (Col. 3 ln. 5-10).
Regarding claim 19, Hunt in view of Creaturo teach the claim limitation of claim 10, where Hunt teaches wherein a new color is visible when the colored seal is aligned with the second color of the plurality of fill indicators (Col. 2 ln. 55-72; where when the colored areas are superimposed with a colored plunger, a new color can be generated and thus meets the claim limitation as set forth by applicant.
Regarding claim 20, Hunt in view of Creaturo teach the claim limitation of claim 15, where Hunt teaches wherein the plurality of fill indicators represent a pair of lines extending around a circumference of the barrel (see fig. 8, 9).
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Creaturo and in view of U.S. Patent No. 1,863,785 to Dickinson (Dickinson).
Regarding claim 7, Hunt and Creaturo teach the claim limitations of claim 1, but fail to teach wherein the colored seal includes bevels that are a different color from the colored seal.
Dickinson teaches the colored seal includes bevels that are a different color from the colored seal (page 1 ln. 97-100, Page 2 ln. 126-130, Page 3 ln. 1-5. 18-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the bevel as a different color from the colored seal in order to allow the mark to be sharply defined and allow for more accurate dosing.
Regarding claim 12, Hunt and Creaturo teach the claim limitations of claim 10, but fail to teach wherein bevels of the colored seal are colored differently from a body of the colored seal.
Dickinson teaches the colored seal includes bevels that are a different color from the colored seal (page 1 ln. 97-100, Page 2 ln. 126-130, Page 3 ln. 1-5. 18-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the bevel as a different color from the colored seal in order to allow the mark to be sharply defined and allow for more accurate dosing.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, Creaturo and in view of JP 3966905.
Regarding claim 7, Hunt and Creaturo teach the claim limitations of claim 1, but fail to teach wherein the colored seal includes bevels that are a different color from the colored seal.
JP 3966905 teahces the colored seal includes bevels that are a different color from the colored seal. (A further advantage of the method according to the invention is seen in that sealing elements with different colors can be produced by using plastics dyed in different colors. In addition, it is possible to produce sealing elements that exhibit different colors in part, for example, by injecting different colored plastics alternately during seal ring injection molding, in a number of different colors in the circumferential or radial direction. It is possible to produce a seal ring exhibiting Such coloring or coloring to partially different colors is useful, for example, for identification applications or wear fatigue index applications for seal elements.)
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the bevel as a different color from the colored seal in order to allow the for identification applications or wear fatigue index applications for seal elements
Regarding claim 12, Hunt and Creaturo teach the claim limitations of claim 10, but fail to teach wherein bevels of the colored seal are colored differently from a body of the colored seal.
JP 3966905 teahces the colored seal includes bevels that are a different color from the colored seal. (A further advantage of the method according to the invention is seen in that sealing elements with different colors can be produced by using plastics dyed in different colors. In addition, it is possible to produce sealing elements that exhibit different colors in part, for example, by injecting different colored plastics alternately during seal ring injection molding, in a number of different colors in the circumferential or radial direction. It is possible to produce a seal ring exhibiting Such coloring or coloring to partially different colors is useful, for example, for identification applications or wear fatigue index applications for seal elements.)
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the bevel as a different color from the colored seal in order to allow the for identification applications or wear fatigue index applications for seal elements
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 1-3, 5, 7-11, and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5, 8-9, 12, and 23-24 of U.S. Patent No. 11071828, hereinafter Pat. No. ‘828, in view of Hunt. Current claims 1, 10, and 15 may be found in claims 1, 23, and 24, respectively, of Pat. No. ‘828. However, Pat. No. ‘828 fails to teach wherein the at least numeric markings and plurality of fill indicators are printed on the barrel. Hunt teaches that is it well known to print volume measuring indicia on a barrel [Col. 1 ln. 68-72, Col. 2 ln. 55-62], as described within the rejections above. Following, current claim 2 may be found in claim 2 of Pat. No. ‘828; current claim 3 may be found in claim 3 of Pat. No. ‘828; current claim 5 may be found in claim 8 of Pat. No. ‘828; current claim 7 may be found in claim 5 of Pat. No. ‘828; current claim 8 may be found in claim 9 of Pat. No. ‘828; current claim 9 may be found in claim 12 of Pat. No. ‘828; current claim 11 may be found in claim 23 of Pat. No. ‘828; current claim 14 may be found in claim 23 of Pat. No. ‘828; and current claim 16 may be found in claim 24 of Pat. No. ‘828.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA E EISENBERG whose telephone number is (571)270-5879. The examiner can normally be reached M-F 8-5.
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.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.
REBECCA E. EISENBERG
Supervisory Patent Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781