Howard Gold

Patent Trials and Appeals Board

Jan 29, 2021

2020004237 (P.T.A.B. Jan. 29, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/067,632 06/15/2011 Howard Gold P-09036 (066810-00234) 4644
47058 7590 01/29/2021
Dickinson Wright - BD
1825 Eye St., NW
Suite 900
WASHINGTON, DC 20006
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
01/29/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
DWPatents@dickinsonwright.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HOWARD GOLD
Appeal 2020-004237
Application 13/067,632
Technology Center 3700
Before BENJAMIN D. M. WOOD, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–3, 6–14, 16, 17, 21, and 22.3 We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellant presented oral argument on January 14, 2020.
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Becton, Dickinson, and Company as
the real party in interest. Appeal Br. 1.
3 Claims 4, 5, 15, and 18–20 are cancelled. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to a syringe with an adjustable plunger dose
stop to control a dosage of medication provided.
Claims 1 and 12 are independent. Claim 1, reproduced below with
emphasis added, is illustrative of the claimed subject matter.
1. A syringe, comprising:
a body for receiving a medicament, said body comprising
a wall;
a collar rotatably disposed in said body, said collar being
rotatable to set a desired dose of the medicament by axially
moving said collar with respect to said body by rotational
movement of said collar with respect to said body;
a handle disposed on said collar outside of said body to
control said rotation of said collar, wherein a periphery of said
handle extends beyond a periphery of said collar;
a plunger movably disposed in said collar, said plunger
being axially movable with respect to said collar to selectively
draw in the medicament, and to dispense the medicament, said
plunger is rotationally fixed with respect to said collar; and
a mechanical stop disposed in said body to stop axial
movement of said plunger with respect to said body according to
a position of said collar with respect to said body when drawing
in the medicament, to limit the medicament drawn in to said set
desired dose defined by axial movement of said plunger from
said wall to said mechanical stop,
wherein said wall defines a position of said plunger with
respect to said body before drawing in the medicament.
Appeal Br. 16 (Claims App.).
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Brown US 3,672,369 June 27, 1972
Swendson US 5,961,472 Oct. 5, 1999
Musick US 2003/0004467 A1 Jan. 2, 2003
Horvath US 2004/0162528 A1 Aug. 19, 2004
Veasey US 2007/0093761 A1 Apr. 26, 2007
Porat US 4,583,978 Apr. 22, 1986
Ogier ’463 FR 2 583 463 A2 Dec. 19, 1986
Ogier ’231 FR 2 575 231 A1 June 27, 1986

REJECTIONS
I. Claims 1, 6–8, 10–14, 16, 17, 21, and 22 are rejected under
35 U.S.C. § 103(a) as unpatentable over Ogier ’463, Horvath, Swendson,
Ogier ’231, Porat,4 and Musick.
II. Claims 2 and 3 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Ogier ’463, Horvath, Swendson, Ogier ’231, Porat,
Musick, and Brown.
III. Claim 9 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Ogier ’463, Horvath, Swendson, Ogier ’231, Musick, Porat, and
Veasey.

4 The headings for the rejections do not list Porat, but the body of Rejection I
discusses how Porat is applied. See Final Act. 2–3, 8–9, and 23–24.
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OPINION
Rejection I (claims 1, 6–8, 10–14, 16, 17, 21, and 22)
Appellant argues for the patentability of the claims subject to the first
ground of rejection, i.e., claims 1, 6–8, 10–14, 16, 17, 21, and 22, as a group.
Appeal Br. 9–13. We select claim 1 as representative of the group, and
claims 6–8, 10–14, 16, 17, 21, and 22 stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
The Examiner finds that Ogier ’463 discloses many of the elements
recited in claim 1, including a plunger movable within a collar, but relies on
Horvath to disclose a plunger with a shape (a cruciform cross-section) that
rotationally fixes the plunger with respect to its collar. See Final Act. 2–6.
Specifically, with respect to Horvath, the Examiner states:
Horvath discloses that the collar may have an opening
therethrough in which the plunger is received (see e.g., Fig. 3)
and that this opening may be either circular in shape (703) or
cruciform in shape (701) wherein the shape of the opening
corresponds to a profile of the plunger rod (Par. 37, 38, and 39)
whereby in configurations with corresponding cruciform shapes
the plunger will be rotationally fixed/constrained with respect to
the collar (see Fig. 6). Horvath discloses that the two shapes are
known, suitable, and alternative configurations for one another
and that the cruciform construction is of “a conventional design.”
Final Act. 6.
The Examiner relies on Swendson as evidence that it is well-known
that a cruciform shape as disclosed by Horvath is “useful in causing
rotational fixation.”5 Id. at 7. The Examiner reasons that implementing the

5 The Examiner finds Ogier ’231, Porat, and Musick disclose other elements
of claim 1, and Appellant does not contest the Examiner’s findings regarding
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cruciform shape disclosed by Horvath in the plunger arrangement disclosed
by Ogier ’463 would have been a simple substitution of known equivalents
requiring only routine skill. Final Act. 6 (citing KSR International Co, v.
Teleflex Inc., 550 US, 398 (2007)). The Examiner provides a modified
version of Figure 1 of Ogier ’463 depicting the proposed modification (Final
Act. 7), which we reproduce below with our annotation identifying the
resultant change in shape to Ogier ’463’s plunger 3.

The Examiner’s modified version of Figure 1 of Ogier ’463 is a
perspective view of tubular element 1 engaged by piston 4. Sliding element

these references or the Examiner’s reasoning for modifying the arrangement
in Ogier ’463 based on them. See Final Act. 8–11; Appeal Br. 9–15.
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(plunger) 3 is connected to piston 4, and, as a result of the Examiner’s
proposed modification, has a cruciform cross-sectional shape.
Appellant argues that, “in contrast to a system where a plunger rod is
rotationally fixed with respect to the collar rotatably disposed in the body
containing medicament, Horvath discloses a system where a limiter can be
added to the housing in order to prevent the plunger from being removed
from the barrel.” Appeal Br. 11. According to Appellant, “[o]ne of ordinary
skill in the art would not have been motivated to further complicate Ogier
[’463] to add [the] limiter of Horvath, or to further complicate the design of
inner cross sections of its plunger 3 and, for example, inner cross section of
its collar 2, in order to add a feature that has nothing to do with the operation
of the device disclosed therein.” Id. at 11–12.
Appellant also contends that “Figures 3(A)-3(C) of Horvath . . . show
[a] cross[-]section view of the system show flange 206 whose diameter is
significantly larger than outer diameter of plunger 18, and therefore,
contrary to the Examiner’s analysis, at least in this embodiment of Horvath,
plunger 18 is not rotationally fixed to outer housing 202.” Appeal Br. 11
(citing Horvath ¶ 34).
With respect to Swendson, Appellant contends that, “[l]ike Horvath,
Swendson does not teach, or even remotely [suggest], a system where a
plunger rod is rotationally fixed with respect to a collar rotatably disposed in
the body containing medicament, as claimed in Appellant’s independent
claims 1 and 12.” Appeal Br. 12. Specifically, Appellant asserts,
“Swendson discloses cap 108 fixed to body 100 such that stem 160 is
rotationally fixed with respect to the body of the blood sampling reservoir.”
Id. In other words, Appellant contends that the rotational fixation disclosed
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by Swendson exists between a cap and a body of a reservoir rather than
between a plunger and a collar as claimed. Based on this assertion,
Appellant concludes, “[c]learly, configuring a plunger/piston to freely rotate
with respect to the body is contrary to Swendson.” Id.
In response, the Examiner emphasizes that Horvath is cited to teach
that a cruciform shape for a syringe plunger is a known alternative to a
circular shape. Ans. 5–10. Specifically, the Examiner states:
[Horvath] discloses that the opening of the collar may
assume a variety of different shapes including circular shapes
(703 - see Fig. 7B - see also Fig. 8) as well as cruciform shapes
(701 - see Figs. 7 A and 6) wherein the shape of the opening
corresponds to the shape of the plunger rod (see Par. 37, 38, and
39). [Horvath] thereby clearly establishes that the two shapes are
alternative constructions to one another and that both shapes
present of “a conventional design.”
Id. at 6 (citing Horvath ¶ 37). In support of the determination that the
circular and cruciform shapes of plunger are known alternatives, the
Examiner explains:
The “housing” of[Horvath], while described in different terms, is
clearly analogous to the identified collar (2) of Ogier [’463], i.e.
movement of the collar is used to set the stroke length of the
piston thereby limited the volume of fluid which can be aspirated
and ejected (see generally Fig. 3-5 of[Horvath]). As such, the
limiter (604/700) when incorporated as part of the housing (see
Fig. 6) can be accurately identified as a collar equivalent to that
of Ogier [’463].
Id. at 12.
As for Appellant’s contention regarding Figures 3A–3C of Horvath,
the Examiner states, “[r]eference to Fig. 3 [of Horvath] merely demonstrates
the invention of [Horvath] to be generally analogous and in the same field of
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endeavor as the syringe of the primary reference, Ogier [’463],” and “Figure
3 is not relied upon, or purported, to demonstrate rotational
constraint/fixation because Figure 3 does not utilize correspondingly shaped
openings which are known to prevent retraction of the plunger from the
collar.” Ans. 10–11.
Regarding Appellant’s assertions as to Swendson, the Examiner notes
“Swendson is supplied as an evidentiary reference establishing that the
configuration shown in [Horvath] (see Fig. 6) would be immediately
recognized by the ordinary artisan as rotatably fixing the collar and piston
(regardless of whether or not the authors of [Horvath] themselves explicitly
discuss such a feature).” Ans. 15.
In reply, Appellant argues:
Contrary to Examiner’s position, one of ordinary skill in the art
of syringes would readily appreciate that rotationally fixing
certain components with respect to each other leads to significant
functional variations in the design and operation of a syringe.
Thus, modification of the relative shape of a collar and a plunger
in order to change the function of syringe components is not a
mere simple substitution of know[n] equivalents.
Reply Br. 2. Thus, Appellant contends the Examiner’s proposed change in
the shape of Ogier ’463’s plunger 3 would result in changes so significant, it
cannot be considered a simple substitution of known equivalents. Appellant
asserts “Horvath’s Figures 7(A)-7(C) do not illustrate a collar, such as
[Ogier ’463’s] collar (2), or a collar rotatably disposed in the body to set a
desired dose of medicament as recited in claims 1 and 12,” and, instead,
Horvath discloses limiter 700, which is intended to prevent plunger 18 from
being removed from barrel 12. Id. at 2–3 (citing Horvath ¶¶ 37–39).
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The Examiner has the better position. The Examiner does not propose
to modify the shape of the plunger disclosed by Ogier ’463 based on the fact
that Horvath uses limiter 700 to prevent removal of plunger 18. Thus, the
fact that the structure on which Horvath’s cruciform-shaped aperture 701 is
located (limiter 700) prevents plunger 18 from being removed from barrel
12, and the fact that Ogier ’463 prevents such removal even without the
Examiner’s proposed modification, does not undermine the Examiner’s
determination that the proposed modification of the shape of Ogier ’463’s
plunger would have been a simple substitution of one known element for
another with predictable results. In other words, Appellant’s argument
regarding this function in Horvath does not address the Examiner’s
reasoning stated on page 6 of the Final Office Action.
Appellant does not dispute the Examiner’s findings that Horvath
discloses a cruciform-shaped plunger or that the result of the changing the
shape of Ogier ’463’s plunger 3 to be cruciform would have been
predictable. See Final Act. 6. Nor does Appellant contest the Examiner’s
finding that Horvath teaches that the aperture containing the plunger “may
be either circular in shape (703) or cruciform in shape (701) wherein the
shape of the opening corresponds to a profile of the plunger rod.” See id.;
Horvath, Figs. 7(A), 7(B). Additionally, Appellant does not traverse the
Examiner’s finding that Swendson supports concluding that Examiner’s
proposed modification would result in a plunger that is rotationally fixed
with respect to the collar in Ogier ’463. See Final Act. 7; Swendson, 8:52–
56). Further, as for Appellant’s allegation that a person of ordinary skill in
the art would not “complicate” Ogier ’463’s plunger design (Appeal Br. 11–
12), Appellant makes no assertion that the proposed modification would
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have been beyond the level of ordinary skill in the art or that any of the
references disparage or otherwise discourage such a modification.
Appellant’s contention that Figures 3(A)–3(C) of Horvath show an
aperture so large that plunger 18 may rotate does not apprise us of Examiner
error because the Examiner relies on Figures 6 and 7(A) of Horvath, not
Figures 3(A)–3(C), to depict plunger limiter 604 having a cruciform-shaped
aperture 701 that is fit (albeit loosely) to the shape of plunger 18. See Final
Act. 6 (citing Horvath ¶¶ 37–39); Ans. 10–12.
Appellant’s arguments regarding Swendson do not apprise us of
Examiner error because Swendson supports a finding that the configuration
shown in Horvath (see Figs. 6, 7(A)) would rotatably fix the plunger to the
collar. See Swendson, 8:47–60. Appellant does not contest this point.
Rather, Appellant identifies elements of Swendson’s structure that are not
relevant to the Examiner’s finding and how this finding is used in the
rejection of claim 1. See Appeal Br. 12.
We have considered all of Appellant’s arguments in support of the
patentability of claim 1, but find them unavailing. Accordingly, we sustain
the rejection of claim 1. Claims 6–8, 10–14, 16, 17, 21, and 22 fall with
claim 1.
Rejections II and III (claims 2, 3, and 9)
Appellant does not make arguments for the patentability of claims 2,
3, and 9 aside from those discussed above regarding claim 1. See Appeal Br.
13–14. Accordingly, for the same reasons, we sustain the rejection of claims
2, 3, and 9.

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CONCLUSION
The Examiner’s rejections are affirmed.

DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1, 6–8, 10–
14, 16, 17,
21, 22
103(a) Ogier ’463, Horvath,
Swendson, Ogier ’231,
Porat, Musick
1, 6–8, 10–
14, 16, 17,
21, 22

2, 3 103(a) Ogier ’463, Horvath,
Swendson, Ogier ’231,
Porat, Musick, Brown
2, 3
9 103(a) Ogier ’463, Horvath,
Swendson, Ogier ’231,
Porat, Musick, Veasey
9
Overall
Outcome
1–3, 6–14,
16, 17, 21,
22

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED