DETAILED ACTION
This Non-Final Rejection replaces the Non-final Rejection dated 3/28/2025 which included an incorrect awarding of priority. As set forth below, the present application does not receive the benefit of priority of the provisional applications as such priority has not been properly claimed in the present application.
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 .
Priority
This application claims priority to non-provisional US Patent Application 15/865,283, filed 1/9/2018, as a continuation-in-part. Although US Patent Application 15/865,283 properly claims priority to provisional applications 62/498,975, 62/499,704, 62/499,872, 62/499,873, 62/499,862, 62/601,840, 62/601,904, 62/601,917, 62/602,138 and 62/707,919, the current application does not properly claim priority to these provisional applications. Therefore, the current application does not receive the priority of these provisional applications. Accordingly, the oldest priority date that the present claims receive is the actual filing date of 15/865,283, which is 1/9/2018.
This application makes reference to or appears to claim subject matter disclosed in at least Application No. 62/498,975, filed 1/10/2017. If applicant desires to claim the benefit of a prior-filed application under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), the instant application must contain, or be amended to contain, a specific reference to the prior-filed application in compliance with 37 CFR 1.78. If the application was filed before September 16, 2012, the specific reference must be included in the first sentence(s) of the specification following the title or in an application data sheet (ADS) in compliance with pre-AIA 37 CFR 1.76; if the application was filed on or after September 16, 2012, the specific reference must be included in an ADS in compliance with 37 CFR 1.76. For benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c), the reference must include the relationship (i.e., continuation, divisional, or continuation-in-part) of the applications.
If the instant application is a utility or plant application filed under 35 U.S.C. 111(a), the specific reference must be submitted during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior application. If the application is a national stage application under 35 U.S.C. 371, the specific reference must be submitted during the pendency of the application and within the later of four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f), four months from the date of the initial submission under 35 U.S.C. 371 to enter the national stage, or sixteen months from the filing date of the prior application. See 37 CFR 1.78(a)(4) for benefit claims under 35 U.S.C. 119(e) and 37 CFR 1.78(d)(3) for benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c). This time period is not extendable and a failure to submit the reference required by 35 U.S.C. 119(e) and/or 120, where applicable, within this time period is considered a waiver of any benefit of such prior application(s) under 35 U.S.C. 119(e), 120, 121, 365(c), and 386(c). A benefit claim filed after the required time period may be accepted if it is accompanied by a grantable petition to accept an unintentionally delayed benefit claim under 35 U.S.C. 119(e) (see 37 CFR 1.78(c)) or under 35 U.S.C. 120, 121, 365(c), or 386(c) (see 37 CFR 1.78(e)). The petition must be accompanied by (1) the reference required by 35 U.S.C. 120 or 119(e) and by 37 CFR 1.78 to the prior application (unless previously submitted), (2) the applicable petition fee under 37 CFR 1.17(m)(1) or (2), and (3) a statement that the entire delay between the date the benefit claim was due under 37 CFR 1.78 and the date the claim was filed was unintentional. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
If the reference to the prior application was previously submitted within the time period set forth in 37 CFR 1.78 but was not included in the location in the application required by the rule (e.g., if the reference was submitted in an oath or declaration or the application transmittal letter), and the information concerning the benefit claim was recognized by the Office as shown by its inclusion on the first filing receipt, the petition under 37 CFR 1.78 and the petition fee under 37 CFR 1.17(m)(1) or (2) are not required. Applicant is still required to submit the reference in compliance with 37 CFR 1.78 by filing an ADS in compliance with 37 CFR 1.76 with the reference (or, if the application was filed before September 16, 2012, by filing either an amendment to the first sentence(s) of the specification or an ADS in compliance with pre-AIA 37 CFR 1.76). See MPEP § 211.02.
Claim Objections
Claim 1 is objected to because of the following informalities: On line 4, the term “a” should be inserted before the term “needle” because every structural element should be preceded by an article. On line 9, the term “major” should be inserted between the terms “front” and “face” to match the language used earlier in the claim. On line 13, the term “graduated” should be inserted between the terms “said” and “scale” to match the language used earlier in the claim. On line 14, the term “the” in the phrase “the quantity” should be replaced with the term “a” since this is the first time this feature is being introduced. On line 14, the term “syringe” should be removed to match the language used earlier in the claim. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: On line 2, the term “a” should be replaced with the term “the” since a “graduated scale” has been introduced in claim 1. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: On line 9, the term “major” should be inserted between the terms “front” and “face” to match the language used earlier in the claim. On line 10, the term “an” should be replaced with the term “outer surface” since such a surface has been introduced earlier in the claim. On line 14, the term “graduated” should be inserted between the terms “said” and “scale” to match the language used earlier in the claim. On line 15, the term “the” in the phrase “the quantity” should be replaced with the term “a” since this is the first time this feature is being introduced. On line 15, the term “syringe” should be removed to match the language used earlier in the claim. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: On line 2, the term “a” should be replaced with the term “the” since a “graduated scale” has been introduced in claim 7. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: On line 5, the term “a” should be inserted before the term “needle” because every structural element should be preceded by an article. On line 10, the term “major” should be inserted between the terms “front” and “face” to match the language used earlier in the claim. On line 14, the term “graduated” should be inserted between the terms “said” and “scale” to match the language used earlier in the claim. On line 15, the term “the” in the phrase “the quantity” should be replaced with the term “a” since this is the first time this feature is being introduced. On line 15, the term “barrel” should be removed to match the language used earlier in the claim. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: On line 2, the term “a” should be replaced with the term “the” since a “graduated scale” has been introduced in claim 1. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: On line 1, the term “barrel” should be replaced with the term “syringe” to match the language of claim 12. Appropriate correction is required.
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.
Claims 1-17 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.
Claim 1 is directed to “A modified barrel” (see line 1) that provides “a more readable display” (see lines 15-16). However, the claim does not set forth what the barrel is “modified” relative to or what the display is compared to in order to determine that it is “more readable”. Therefore, the inclusion of the terms “modified” and “more” render the claim indefinite. It is suggested to remove these terms from the claim. Claims 2-6 are rejected due to their dependence on claim 1.
Claim 7 is directed to a syringe that provides “a more readable display” (see lines 15-16). However, the claim does not set forth what the display is compared to in order to determine that it is “more readable”. Therefore, the inclusion of the term “more” renders the claim indefinite. It is suggested to remove this term from the claim. Claims 8-11 are rejected due to their dependence on claim 7.
Claim 7 recites “said predetermined standard” on line 16, but this phrase lacks proper antecedent basis since two predetermined standards have been introduced prior to this phrase (see line 13 and line 14) and it is unclear as to which of these standards that the phrase on line 16 is intended to refer. Additionally, the phrase “said predetermined standard” in claims 10 and 11 also lack antecedent basis for the same reasons. It is suggested to amend claim 7, 10 and 11 to clarify which of the two standards of claim 7 that each of these phrases refer to. Claims 8-11 are rejected due to their dependence on claim 7.
Claim 12 is directed to a syringe with “a more readable display” (see line 1 and lines 16-17). However, the claim does not set forth what the display is compared to in order to determine that it is “more readable”. Therefore, the inclusion of the term “more” renders the claim indefinite. It is suggested to remove this term from the claim. Claims 13-17 are rejected due to their dependence on claim 12.
Claim Rejections - 35 USC § 102
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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Grigoreas et al. (PG PUB 2020/0289761).
Re claim 1, Grigoreas discloses a modified barrel 12+14 (Fig 2,3; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for a syringe 10 comprising: an elongate body portion 14 having a side wall (the portion of 14 extending from proximal end 22 to distal end 24) defining a cylindrical lumen (as seen in Fig 4), said lumen having a longitudinal axis (extending horizontally in Fig 2,3), said body portion having an open proximal end (to the left in Fig 2) and a distal end (to the right in Fig 2) having a passageway for conveying contents in said lumen to a hollow nozzle 30A, said side wall having an outer surface 20 and a generally oblong projection 14 in longitudinal alignment with said side wall and said body portion (as seen in Fig 2,3), said projection extending laterally outwardly and away from said outer surface of said side wall in a single general direction (as seen in Fig 3,4), said projection extending longitudinally to a distal limit of said lumen (as seen in Fig 2, the projection and the lumen end at 24); said projection having a front major face 56 and a rear face 58, said front face being generally planar (as seen in Fig 3,4) and being contiguous along a continuous inner longitudinal edge with said outer surface of said side wall (as seen in Fig 2); and, at least one of said faces bearing at least part of a graduated scale 62+64; said scale being in compliance with a predetermined standard for an indicating scale for indicating the quantity of medicament in said syringe barrel (as seen in Fig 2); whereby said syringe is in compliance with said predetermined standard and provides a more readable display (as seen in Fig 2).
Re claim 2, Grigoreas discloses that said graduated scale comprises a plurality of incremental line markings 62 and numerical markings 64.
Re claim 3, Grigoreas discloses that said predetermined standard is by the International Organization for Standardization (as seen in Fig 2).
Re claim 4, Grigoreas discloses that said at least one of said faces has sufficient dimensions for displaying a graduated scale in accordance with said standard by the International Organization for Standardization (as seen in Fig 2).
Re claim 5, Grigoreas discloses that a part of said graduated scale appears on said outer surface of said side wall (as seen in Fig 2).
Re claim 6, Grigoreas discloses that said barrel is for an insulin syringe (inherent since syringe 10 can be used to hold any medicament, including insulin; it is noted that the claim does not require the invention to include insulin).
Re claim 7, Grigoreas discloses a barrel 12+14 (Fig 2,3; it is noted that all reference characters cited below refer to Fig 2 unless otherwise noted) for an insulin syringe 10 (it is noted that the “insulin syringe” is only functionally recited and, therefore, not a part of the invention; it is also noted that syringe 10 can be used to hold any medicament, including insulin, and an “insulin syringe” does not have any special structure that differs it from the syringe of Grigoreas) comprising: an elongate body portion 14 having a side wall (the portion of 14 extending from proximal end 22 to distal end 24) defining a cylindrical lumen (as seen in Fig 4) with a longitudinal axis (extending horizontally in Fig 2,3), said body portion having an open proximal end (to the left in Fig 2) and a distal end (to the right in Fig 2) having a passageway therethrough in communication with said lumen (as seen in Fig 6); said side wall having an outer surface 20 and a generally oblong projection 14 in longitudinal alignment with said side wall and said body portion (as seen in Fig 2,3), said projection extending laterally outwardly and away from said outer surface of said side wall in a single general direction (as seen in Fig 3,4), said projection extending longitudinally to a distal limit of said lumen (as seen in Fig 2, the projection and the lumen end at 24); said projection having a front major face 56 and a rear face 58, said front face being generally planar (as seen in Fig 3,4) and being contiguous along a continuous inner longitudinal edge with said outer surface of said side wall (as seen in Fig 2); and, at least one of said faces bearing at least part of a graduated scale 62+64; said barrel being in compliance with a predetermined legal standard for an insulin syringe (as seen in Fig 2), and said scale being in compliance with a predetermined standard for an indicating scale for indicating the quantity of medicament in said syringe barrel (as seen in Fig 2), whereby said syringe is in compliance with said predetermined standard and provides a more readable display (as seen in Fig 2).
Re claim 8, Grigoreas discloses that a part of said graduated scale appears on said outer surface of said side wall (as seen in Fig 2).
Re claim 9, Grigoreas discloses that said graduated scale comprises a plurality of incremental line markings 62 and numerical markings 64.
Re claim 10, Grigoreas discloses that said predetermined standard is by the International Organization for Standardization (as seen in Fig 2).
Re claim 11, Grigoreas discloses that said at least one of said faces has sufficient dimensions for displaying a graduated scale in accordance with said standard by the International Organization for Standardization (as seen in Fig 2).
Re claim 12, Grigoreas discloses a method of providing a syringe 10 (Fig 2,3; it is noted that all reference characters cited below refer to Fig 2,3 unless otherwise noted) with a more readable display (as seen in Fig 2), comprising; providing an elongate body portion 14 having a side wall (the portion of 14 extending from proximal end 22 to distal end 24) having an outer surface 20 and defining a cylindrical lumen (as seen in Fig 4), said lumen having a longitudinal axis (extending horizontally in Fig 2,3), said body portion having an open proximal end (to the left in Fig 2) and a distal end (to the right in Fig 2) having a passageway for conveying contents in said lumen to a hollow nozzle 30A, providing a projection 14 extending laterally outwardly and away from said outer surface of said side wall in a single general direction (as seen in Fig 3,4), said projection extending longitudinally to a distal limit of said lumen (as seen in Fig 2, the projection and the lumen end at 24), said projection being generally oblong (as seen in Fig 2) and longitudinally aligned with said side wall and said body portion (as seen in Fig 3,4), said projection having a front major face 56 and a rear face 58, said front face being generally planar (as seen in Fig 3,4) and being contiguous along a continuous inner longitudinal edge with said outer surface of said side wall (as seen in Fig 2); and, at least one of said faces bearing at least part of a graduated scale 62+64; said scale being in compliance with a predetermined standard for an indicating scale for indicating the quantity of medicament in said syringe barrel (as seen in Fig 2); whereby said syringe is in compliance with said predetermined standard and provides a more readable display (as seen in Fig 2).
Re claim 13, Grigoreas discloses that said graduated scale comprises a plurality of incremental line markings 62 and numerical markings 64.
Re claim 14, Grigoreas discloses that said predetermined standard is by the International Organization for Standardization (as seen in Fig 2).
Re claim 15, Grigoreas discloses that said at least one of said faces has sufficient dimensions for displaying a graduated scale in accordance with said standard by the International Organization for Standardization (as seen in Fig 2).
Re claim 16, Grigoreas discloses that a part of said graduated scale appears on said outer surface of said side wall (as seen in Fig 2).
Re claim 17, Grigoreas discloses that said barrel is provided for holding and dispensing insulin (inherent since syringe 10 can be used to hold any medicament, including insulin; it is noted that the claim does not require the invention to include insulin).
Allowable Subject Matter
If Applicant were to properly claim priority to provisional application 62/498,975, then the above-cited Grigoreas reference would no longer qualify as prior art and claims 1-17 would be allowable if rewritten or amended to overcome the objections and rejections under 35 U.S.C. 112(b) set forth in this Office action. The closest prior art of record would be US Pat 6,120,481 to Rennert et al. and FR2693909 to Watts (an English translation of which is provided in the parent application folder on 6/27/2019), but neither of these references disclose alone or in combination all of the features of independent claims 1, 7 and 12. Rennert discloses a syringe barrel 12 (Fig 1) comprising an elongate body portion (the entirety of the syringe barrel seen in Fig 1 except for the proximal flange and the distal tip) having a side wall (defined by surfaces 20,24) defining a cylindrical lumen 28 (Fig 3), the side wall having an outer surface (seen in Fig 3) and a generally oblong projection 40 in longitudinal alignment with the side wall and the body portion (as seen in Fig 1,3), extending laterally outwardly and away from the outer surface of the side wall in a single general direction (as seen in Fig 3), and extending longitudinally to a distal limit of said lumen (as seen in Fig 1), wherein the projection has a front major face and a rear face (the faces facing left and right in Fig 3), and at least one of the faces bearing at least part of a graduated scale 30+48, wherein the scale and the syringe are in compliance with a predetermined standard for indicating scale for indicating a quantity of medicament in the barrel (as seen in Fig 1); however, Rennert’s front major face is not generally planar and contiguous along a continuous inner longitudinal edge with the outer surface of the side wall as claimed due to the presence or rings 48 being formed thereon ; additionally, it would not have been obvious to modify Rennert to include the projection such that it is arranged in this manner as doing so would render Rennert inoperable for its intended purpose. Watts discloses a syringe barrel 32 (Fig 2-4) comprising an elongate body portion (the entirety of barrel 32 extending between the flange 30 and the tip 26) having a side wall (the cylindrical wall forming barrel 32) defining a cylindrical lumen 34, the side wall having an outer surface (seen in Fig 4) and a generally oblong projection 36 in longitudinal alignment with the side wall and the body portion (as seen in Fig 2), extending laterally outwardly and away from the outer surface of the side wall (as seen in Fig 4), and extending longitudinally to a distal limit of said lumen (as seen in Fig 2), wherein the projection has a front major face 38 and a rear face (seen in Fig 4, opposite the face 38, the front major face being generally planar (as seen in Fig 4) and bearing at least part of a graduated scale 40,42, wherein the scale and the syringe are in compliance with a predetermined standard for indicating scale for indicating a quantity of medicament in the barrel (as seen in Fig 2); however, Watt’s projection does not extend in a single general direction and the front major face is not contiguous along a continuous inner longitudinal edge with the outer surface of the side wall as claimed; additionally, it would not have been obvious to modify Watt’s to include the projection such that it is arranged in this manner as doing so would require substantial redesign absent a teaching to do so. Additionally, a barrel comprising all of the claimed components could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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, Kevin Sirmons can be reached on (571)272-4965. 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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783