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 4-6 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 protruding element” is indefinite because it is unclear if it is the same or different from the protruding element of claim 1. Thereafter, “the protruding element” is indefinite because it is unclear which element is being referred to.
Furthermore in claims 4 and 5, “the one or more plunger rod abutting surfaces” lacks antecedent basis.
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) 1-4, 7-14, 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4073321 (Moskowitz) in view of US 2021/0330887 (Langley).
Regarding claim 1, Moskowitz teaches a plunger rod insertion gauge for a precision dose delivery device including a plunger rod (Fig 1; rod 5), the insertion gauge comprising: an insertion gauge body including a handle portion and a gauge portion (Fig 1; handle portion construed as the middle portion of 10 and 40/41; gauge portion construed as the ends of 10 and 40/41; the insertion gauge includes both 10 and 39); wherein the gauge portion includes: one or more plunger rod abutting surfaces (plunger rod abutting surface 16); one or more flange abutting surfaces oriented substantially perpendicular to a plunger rod insertion axis (flange abutting surface 13 perpendicular to the plunger rod insertion axis – see Fig 1); a protruding element configured to abut against a thumb pad of the plunger rod to inhibit proximal movement of the plunger rod (protruding element 42 abuts against thumb pad 7; col 4 ll. 7-col 5 l. 2); 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 (col 4 ll. 3-50; dimension between the ends of regulator 10 defines maximum plunger rod insertion depth).
Moskowitz fails to teach a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod. However, Langley teaches a gauge spacer configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod (Fig 8A-8D; annotations below; para 216-224). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod in order to control movement of the plunger during different steps, as taught by 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, a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod yields predictable results (controlling movement of the plunger rod).
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Regarding claim 2-4, 7-8, Moskowitz in view of Langley teaches the gauge spacer surface is configured to abut a distal portion of the protrusion on the plunger rod that is located between a top surface of the thumb pad of the plunger rod and a top surface of a flange portion of the precision dose delivery device (Moskowitz Fig 1; gauge spacer 10 is between the top surface of thumb pad 7 and top surface of flange portion 9; Langley Fig 8D; the gauge spacer surface is configured to abut a distal portion of the protrusion on the plunger rod that is located between a top surface of the thumb pad 1482 of the plunger rod and a top surface of a flange portion 1440 of the precision dose delivery device), the protruding element is configured to abut the top surface of the thumb pad of the plunger rod (Moskowitz Fig 1, col 4 ll. 7-col 5 l. 2; top surface of 7 abuts 42), the distal portion of the protrusion on the plunger rod is a protruding element and wherein the one or more plunger rod abutting surfaces include at least one vertical surface configured to abut a side surface of the protruding element while the gauge spacer surface abuts a bottom surface of the protruding element (annotated above; when the protrusion sits in the corner of the passage, it will contact both the vertical surface and the gauge spacer surface; side surface annotated above; furthermore, “configured to abut …” is a statement of intended use and does not differentiate the claimed structure from the prior art; Moskowitz teaches a vertical surface that “is configured to abut” -e.g. capable of abutting -a side surface); wherein the top surface of the flange portion is the top surface of a proximal collar of the flange portion (Moskowitz, top surface of a proximal collar 9), the handle portion includes one or more features to aid a user in grasping the insertion gauge (e.g. its length or thickness or edges).
Regarding claim 9, Moskowitz teaches a plunger rod insertion gauge for a precision dose delivery device including a plunger rod (Fig 1; rod 5), the insertion gauge comprising: a gauge spacer comprising a first gauge spacer surface and a second gauge spacer surface (gauge spacer 10 with first surface 16 and second surface 13); a receiving block positioned adjacent to the gauge spacer and comprising a first receiving block surface and a second receiving block surface (receiving block 40, 41 or 30 comprising a first receiving block surface – e.g. a surface of 40 or surface of 31 – and a second receiving block surface – e.g. a surface of 41 or surface of 32); and a protruding element positioned above the receiving block and configured to abut against a thumb pad of the plunger rod to inhibit proximal movement of the plunger rod (protruding element 42 abuts against thumb pad 7; col 4 ll. 7-col 5 l. 2); 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 (col 4 ll. 3-50; dimension between the ends of regulator 10 defines maximum plunger rod insertion depth).
Moskowitz fails to teach the first gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod. However, Langley teaches a gauge spacer configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod (Fig 8A-8D; annotations above; para 216-224). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod in order to control movement of the plunger during different steps, as taught by 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, a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod yields predictable results (controlling movement of the plunger rod).
Regarding claim 10-14, Moskowitz in view of Langley teaches wherein the receiving block further comprises a first receiving wall and wherein the first receiving wall is arcuate-shaped (Moskowitz Fig 1; first arcuate receiving wall 31), the first receiving wall is configured to abut a first part of an actuation portion of the plunger rod of the precision dose delivery device that is disposed distally from the thumb pad (Fig 1, col 3 l. 18-col 4 l. 2; the portion of rod 5 received in 31 is “a first part of an actuation portion”), a receiving area defined between the first receiving block surface of the receiving block and a first surface of the protruding element, the thumb pad of the plunger rod is configured to reside in the receiving area (“receiving area” is the space between a first surface of 42 – e.g. either the proximal or distal surface - and 31; thumb pad is inside the receiving area), wherein the second gauge spacer surface is configured to abut a portion of a flange component of the precision dose delivery device (13 abuts a portion of flange component 9).
Regarding claim 21, Moskowitz teaches a plunger rod insertion gauge for a precision dose delivery device including a body, a flange, and a plunger rod (Fig 1; body 3, flange 9, plunger rod 5/7), the plunger rod insertion gauge comprising: a flange abutting surface configured to abut against the flange (gauge spacer 10 with a flange abutting surface 13 – see col 4 ll. 10-24); a protruding element configured to abut against a thumb pad of the plunger rod to inhibit proximal movement of the plunger rod relative to the flange and the body (protruding element 42 abuts against thumb pad 7; col 4 ll. 7-col 5 l. 2); and wherein a dimension measured between the gauge spacer surface and the flange abutting surface defines a maximum insertion depth for the plunger rod relative to the body (col 4 ll. 3-50; dimension between the ends of regulator 10 defines maximum plunger rod insertion depth).
Moskowitz fails to teach the first gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod relative to the flange and the body. However, Langley teaches a gauge spacer configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod (Fig 8A-8D; annotations above; para 216-224). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod relative to the flange and the body in order to control movement of the plunger during different steps, as taught by 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, a gauge spacer surface configured to abut against a protrusion of the plunger rod that extends distally from the thumb pad to inhibit distal movement of the plunger rod relative to the flange and the body yields predictable results (controlling movement of the plunger rod).
Regarding claim 22-26, Moskowitz in view of Langley teaches a first receiving surface that is configured to receive an actuation portion of the plunger rod that is disposed distally of the thumb pad (Moskowitz Fig 1, col 3 l. 18-col 4 l. 2; first receiving surface of 31; the portion of rod 5 received in 31 is “an actuation portion”, distal of the thumb pad), a second receiving surface positioned between the protruding element and the first receiving surface, wherein the second receiving surface is configured to abut against a side surface of the thumb pad of the plunger rod; and wherein the second receiving surface is longitudinally misaligned relative to the first receiving surface (annotated below; second receiving surface is between 42 and 31, and longitudinally misaligned relative to the first receiving surface – e.g. longitudinally offset; “configured to abut …” is a statement of intended use and does not differentiate the claimed structure from the prior art; Moskowitz teaches a second receiving surface that “is configured to abut” a side surface – e.g. the surface is capable of abutting a side surface), a first gauge spacer and a second gauge spacer that are positioned such that a side surface of the plunger rod is configured to be positioned between the first gauge spacer and the second gauge spacer (first gauge spacer 39 and/or 30; second gauge spacer 10; side surface of plunger rod 5 is between them – see Fig 1), a handle portion extending perpendicularly relative to an insertion axis of the plunger rod into the plunger rod insertion gauge (Fig 1; handle portion construed as the middle portion of 10 and 40/41, each of which has a dimension extending perpendicularly relative to an insertion axis of the plunger rod into the plunger rod insertion gauge), the flange abutting surface is configured to abut a proximal collar of the flange of the precision dose delivery device to separate the protrusion from the proximal collar (surface 13 abuts top surface of a proximal collar 9).
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Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4073321 (Moskowitz) in view of US 2021/0330887 (Langley), and further in view of US 2021/0060257 (Baker).
Regarding claims 5-6, Moskowitz in view of Langley further teaches the one or more plunger rod abutting surfaces include a first receiving surface and a second receiving surface (Moskowitz; annotated below; first receiving surface is surface of 31) and wherein the thumb pad of the plunger rod includes a first actuation portion and a proximal body of the plunger rod includes a second actuation portion (first actuation portion is at least a portion of the thumb pad -e.g. the side portion of the thumb pad 7; second actuation portion is a proximal portion of rod 5, received by 31), wherein the first receiving surface is configured to abut the proximal body defined by the second actuation portion of the plunger rod (first receiving surface of 31 receives the second actuation portion) and wherein the second receiving surface is configured to abut the thumb pad defined by the first actuation portion of the plunger rod (the second receiving surface is adjacent to the first actuation portion – e.g. adjacent to the thumb pad; “configured to abut …” is a statement of intended use and does not differentiate the claimed structure from the prior art; Moskowitz teaches a second receiving surface that “is configured to abut” a side surface – e.g. the surface is capable of abutting a side surface), wherein the first receiving portion is positioned below the second receiving surface (Fig 1) 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).
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Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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