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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I in the reply filed on 12/17/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 4 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. “at least one surface configured to abut a bottom surface” is indefinite because it is unclear if it is the same or different from the “at least one surface configured to abut a portion of a plunger rod” of claim 2.
Claim 10-11 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. “a first receiving surface” is indefinite because it is unclear if it is the same or different from the “first receiving block surface” of claim 9.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 3770026 (Isenberg).
Regarding claim 1-2, 4, 7-8, Isenberg teaches a plunger rod insertion gauge for a precision dose delivery device (Fig 1), the insertion gauge comprising: an insertion gauge body including a handle portion and a gauge portion (annotated below; gauge body 26); wherein the gauge portion includes one or more plunger rod abutting surfaces (28b) and one or more flange abutting surfaces (28a) oriented substantially perpendicular to a plunger rod insertion axis (plunger rod insertion axis going left to right in Fig 1; 28a and 28b extend perpendicular to the insertion axis); and wherein a dimension measured between the one or more plunger rod abutting surfaces and the one or more flange abutting surfaces defines a maximum plunger rod insertion depth for the precision dose delivery device (with the gauge mounted on the plunger, the gauge prevents further movement of the plunger when 28a and 28b are in contact with the flange and the plunger rod; the insertion depth is therefore defined by the dimension between 28a and 28b – col 3 ll. 14-65), the one or more plunger rod abutting surfaces include at least one surface configured to abut a portion of a plunger rod located between a top surface of the plunger rod and a top surface of a flange portion of the precision dose delivery device (surface 28b abuts a surface of 18 that is between the top surface and a top surface of a flange portion 22 of the device), the portion of the plunger rod is a protruding element (18 is a protruding element; see Fig 1-2, protruding from shaft 20) and wherein the one or more plunger rod abutting surfaces include at least one surface configured to abut a bottom surface of the protruding element (surface 28b abuts bottom surface of 18), the top surface of the flange portion is the top surface of a proximal collar of the flange portion (annotated below; proximal collar of flange portion 22; top surface of 22 abuts 28a), the handle portion includes one or more features to aid a user in grasping the insertion gauge (Fig 2; curved surfaces of 36 to aid grasping).
PNG
media_image1.png
422
635
media_image1.png
Greyscale
Regarding claim 1-3, in another embodiment, Isenberg teaches a plunger rod insertion gauge for a precision dose delivery device (Fig 4), the insertion gauge comprising: an insertion gauge body including a handle portion and a gauge portion (annotated below); wherein the gauge portion includes one or more plunger rod abutting surfaces (annotated below) and one or more flange abutting surfaces (annotated below) oriented substantially perpendicular to a plunger rod insertion axis (plunger rod insertion axis going left to right; abutting surfaces extend perpendicular to the insertion axis); and wherein a dimension measured between the one or more plunger rod abutting surfaces and the one or more flange abutting surfaces defines a maximum plunger rod insertion depth for the precision dose delivery device (with the gauge mounted on the plunger, the gauge prevents further movement of the plunger when the abutting surfaces are in contact with the flange and the plunger rod; the insertion depth is therefore defined by the dimension between), the one or more plunger rod abutting surfaces include at least one surface configured to abut a portion of a plunger rod located between a top surface of the plunger rod and a top surface of a flange portion of the precision dose delivery device (plunger rod abutting surface configured to abut a surface of 18 that is between the top surface and a top surface of a flange portion of the device; e.g. the bottom surface of 18 is adjacent to and may move into abutment with the plunger rod abutting surface), the one or more plunger rod abutting surfaces include at least one surface configured to abut the top surface of the plunger rod (annotated below).
PNG
media_image2.png
284
529
media_image2.png
Greyscale
Claim(s) 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0247585 (Gerlett).
Regarding claim 9-13, Gerlett teaches a plunger rod insertion gauge for a precision dose delivery device (Fig 1, 16a-16b), the insertion gauge comprising: a gauge spacer comprising a first gauge spacer surface and a second gauge spacer surface (annotated below); a receiving block positioned adjacent to the gauge spacer and comprising a first receiving block surface and a second receiving block surface (annotated below); and a protruding element positioned above the receiving block (protruding element 211); wherein a dimension between the first gauge spacer surface and the second gauge spacer surface defines a maximum plunger rod insertion depth for the precision dose delivery device (dimension between the first and second gauge spacer surface defines a length including part of the length which prevents the plunger from moving forward, therefore defining maximum insertion depth), the receiving block further comprises a first receiving surface and wherein the first receiving surface is arcuate-shaped (annotated below), wherein the first receiving surface is configured to abut a first part of an actuation portion of a plunger rod of the precision dose delivery device (Fig 16B; first receiving surface abuts a bottom surface of 211, construed as an actuation portion of a plunger rod), a receiving area defined between the first receiving block surface of the receiving block and a first surface of the protruding element (Fig 16A; receiving area between the first receiving surface and the inner surface of 211, labeled as D1), wherein a second part of an actuation portion of a plunger rod of the precision dose delivery device is configured to reside in the receiving area (annotated below).
PNG
media_image3.png
423
593
media_image3.png
Greyscale
PNG
media_image4.png
367
337
media_image4.png
Greyscale
Claim(s) 9, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0106763 (Meyer).
Regarding claim 9, 14, Meyer teaches a plunger rod insertion gauge for a precision dose delivery device (Fig 14A), the insertion gauge comprising: a gauge spacer comprising a first gauge spacer surface and a second gauge spacer surface (para 72-73, 83, Fig 8-9, 14A, 15A; gauge spacer 500 including first gauge spacer surface 532 and second gauge spacer surface inside slot 514 that engages the flange 712); a receiving block positioned adjacent to the gauge spacer and comprising a first receiving block surface and a second receiving block surface (receiving block 630 with first receiving block surface 632 and second receiving block surface annotated below); and a protruding element positioned above the receiving block (Fig 15A; protruding element 622 or 722); wherein a dimension between the first gauge spacer surface and the second gauge spacer surface defines a maximum plunger rod insertion depth for the precision dose delivery device (stop surface 532 stops the plunger from moving farther; the surface abutting flange 712 determines the distance of the plunger flange 722 from the flange; dimension between the first and second gauge spacer surface defines a length including part of the length which prevents the plunger from moving forward, therefore defining maximum insertion depth), wherein the first gauge spacer surface is configured to abut a portion of a plunger rod of the precision dose delivery device (para 73; first gauge spacer surface 532 abuts a portion 722 of a plunger rod) and wherein the second gauge spacer surface is configured to abut a portion of a flange component of the precision dose delivery device (para 83; second gauge spacer surface inside 514 abuts a portion of a flange component 712).
PNG
media_image5.png
401
456
media_image5.png
Greyscale
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 3770026 (Isenberg) in view of US 2021/0060257 (Baker) and US 2021/0330887 (Langley).
Regarding claims 5-6, Isenberg further teaches the one or more plunger rod abutting surfaces include a first receiving surface and a second receiving surface (annotated below) and wherein the portion of the plunger rod includes a first actuation portion (18) and a second actuation portion (the shaft 20 below the disk 18), wherein the first receiving surface is configured to abut the second actuation portion of the plunger rod (see Fig 2, 4; col 4 ll. 41-55; first receiving surface is adjacent to and configured to abut the second actuation portion) and wherein the second receiving surface is configured to abut the first actuation portion of the plunger rod (annotated below), wherein the first receiving portion is positioned below the second receiving surface (annotated below) but fails to teach wherein the first actuation portion is torus-shaped and wherein the second actuation portion is cylindrically-shaped. However, Baker teaches that the plunger rod/shaft may be a number of different shapes, including cylindrical (para 35). Langley teaches that the disk at the end of the plunger may be torus-shaped (Fig 34-35; torus 2887). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the first actuation portion torus-shaped and wherein the second actuation portion cylindrically-shaped, as taught by Baker and Langley. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the first actuation portion torus-shaped and the second actuation portion cylindrically-shaped yields predictable results (actuation of the plunger).
PNG
media_image6.png
343
517
media_image6.png
Greyscale
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2008/0234636 teaches a gauge portion positioned between a flange portion and a plunger rod portion (Fig 7). US 2016/0081849 teaches a gauge spacer and a receiving block (Fig 35, 36).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat (Pat) Wongwian can be reached at 571-270-5426. 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.
/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741