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 .
Election/Restrictions
Applicant's election with traverse of Species A (Figs. 71-73; Clm. 1-4, 6, 13-16) in the reply filed on 22 April 2026 is acknowledged.
Claim(s) 5, 7-12, and 17-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The traversal is on the ground(s) that there would not be a burdensome search. This is not found persuasive. While the noted species do share the common concept of a “spacer” for use in the same overlying drug delivery device, they represent separate and distinct subcombination articles wherein the spacers are not recited as being used simultaneously with one another, but rather are presented as alternatives to one another with one spacer species replacing the other spacer species in operation in the drug delivery device. The spacers are substantially different in structure and are assembled and operate for adjustment in materially different manners. While search will necessary involve some degree of overlap, given the tens of thousands of prior art documents which require consideration and the fact that a generic “spacer assembly” (as claimed) will not occupy a singular, concentrated collection of art, substantial search considerations must be placed on the divergent features of these spacer groups whereby requiring search and examination for every single manner in which these spacer species diverge from one another would substantially increase the scope and complexity of the search and would certainly require the application of separate and different pieces of prior art to account for these structural differences.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-4, 6, 14-17 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,201,817 (“Avery”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, Avery claims, inter alia, a spacer assembly (see Clm. 1 or 9)
comprising:
a stopper (see Clm. 1 or 9); and
a spacer (see Clm. 1 or 9) attached to the stopper (see Clm. 2 or 4), the spacer comprising:
a fixed portion (re: the “holder”) fixedly connected to the stopper (see Clm. 2 or 4); and
an adjustable portion (re: the “spacer element” axially displaceable with respect to the fixed portion (see Clm. 1 or 9).
Regarding Claim 2, Avery claims that the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (see Clm. 1 or 9).
Regarding Claim 3, Avery claims the adjustable portion is rotationally displaceable with respect to the fixed portion in a single direction (see Clm. 1 and 9, re: “permit rotation and axial displacement of the spacer element away from the holder”; see also Clm. 5, re: “prevent rotation and axial displacement of the spacer element toward the holder”).
Regarding Claim 4, Avery claims the spacer is threadably attached to the stopper (see Clm. 2 or 10).
Regarding Claim 6, Avery fails to claim a syringe barrel, wherein the stopper is at least partially disposed within the syringe barrel. However, such a limitation is obvious in view of the claimed “drug delivery system” of Avery in association with the understood operation of a “plunger” when used in association with a “drug delivery system” is clearly evocative of a barrel, in which the plunger is received, in order to serve as a reservoir of drug to be dispensed.
Regarding Claim 14, Avery claims (see Clm. 1 or 9) a drive assembly for a drug delivery system, the drive assembly comprising:
a plunger member configured to engage and move a stopper within a container, the plunger member having a first position and a second position axially spaced from the first position;
a biasing member configured to move the plunger member from the first position to the second position; and
an adjustable spacer positioned between the plunger member and the stopper,
the adjustable spacer comprising:
a fixed portion (re: the “holder”); and
an adjustable portion (re: the “spacer element”) axially displaceable with respect to the fixed portion.
Regarding Claim 15, Avery recites the adjustable portion is rotationally displaceable with respect to the fixed portion (see Clm. 1 or 9), and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (see Clm. 1 or 9).
Regarding Claim 16, Avery recites the adjustable portion is rotationally displaceable with respect to the fixed portion in a single direction (see Clm. 5, 8, 13, 16).
Claim(s) 1-4, 6, 14-16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of U.S. Patent No. 11,357,918 (“Avery ‘918”) in view of U.S. Publication No. 2008/0039789 (“Wyrick”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, Avery claims, inter alia, a spacer assembly (see Clm. 1 or 3)
comprising:
a stopper; and
a spacer engaged with the stopper, the spacer comprising:
a fixed portion (re: the “holder”) engaged with the stopper; and
an adjustable portion (re: the “spacer element” axially displaceable with respect to the fixed portion.
While Avery does not claim that the fixed portion is “fixedly” connected to the stopper, such a configuration is known in prior art spacers (see Fig. 6, 7 – Wyrick) wherein a stopper and fixed spacer portion are fixedly connected to one another via a threaded interconnection to permit them to move together and thereby would have been obvious to include in association with the invention of Avery.
Regarding Claim 4, Avery fails to claim that the spacer is threadably attached to the stopper. However, the use of such a threaded engagement is obvious (see Wyrick wherein 14 and 63 are threaded together to fix their position).
Regarding Claim 6, Avery claims a syringe barrel (RE: “container), wherein the stopper is at least partially disposed within the syringe barrel.
Regarding Claim 14, Avery claims (see Clm. 1 or 3) a drive assembly for a drug delivery system, the drive assembly comprising:
a plunger member configured to engage and move a stopper within a container, the plunger member having a first position and a second position axially spaced from the first position;
a biasing member configured to move the plunger member from the first position to the second position; and
an adjustable spacer positioned between the plunger member and the stopper,
the adjustable spacer comprising:
a fixed portion (re: the “holder”); and
an adjustable portion (re: the “spacer element”) axially displaceable with respect to the fixed portion.
While Avery does not claim that the fixed portion is “fixedly” connected to the stopper, such a configuration is known in prior art spacers (see Fig. 6, 7 – Wyrick) wherein a stopper and fixed spacer portion are fixedly connected to one another via a threaded interconnection to permit them to move together and thereby would have been obvious to include in association with the invention of Avery.
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, 2, 4, 6, 14, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2008/0039789 (“Wyrick”).
Regarding Claim 1, Wyrick discloses a spacer assembly, comprising:
a stopper (14); and a
spacer (62, 63) attached to the stopper (see via the threaded connection between 63 and 14), the spacer comprising:
a fixed portion (63) fixedly connected (via the threaded connection) to the stopper; and
an adjustable portion (62) axially displaceable with respect to the fixed portion (Par. 76, 77).
Regarding Claim 2, Wyrick discloses the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (Par. 76, 77).
Regarding Claim 4, Wyrick discloses the spacer is threadably attached to the stopper (see Fig. 7).
Regarding Claim 6, Wyrick discloses a syringe barrel (12), wherein the stopper is at least partially disposed within the syringe barrel (see Fig. 7).
Regarding Claim 14, Wyrick discloses a drive assembly for a drug delivery system, the drive assembly comprising:
a plunger member (37) configured to engage and move a stopper (14) within a container (12), the plunger member having a first position (Fig. 3) and a second position (e.g. Fig. 6) axially spaced from the first position;
a biasing member (50) configured to move the plunger member from the first position to the second position (Par. 74); and
an adjustable spacer (62, 63) positioned between the plunger member and the stopper (see Fig. 7), the adjustable spacer comprising:
a fixed portion (63); and
an adjustable portion (62) axially displaceable with respect to the fixed portion (76, 77).
Regarding Claim 15, Wyrick discloses the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (Par. 76, 77).
Claim(s) 1, 2, 3, 6, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2013/0304021 (“Cabiri”).
Regarding Claim 1, Cabiri discloses a spacer assembly, comprising:
a stopper (222); and
a spacer attached to the stopper, the spacer comprising:
a fixed portion (220) fixedly connected to the stopper; and
an adjustable portion (230, 240) axially displaceable with respect to the fixed portion (see Fig. 2A, 2B).
Regarding Claim 2, Cabiri discloses the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (Par. 76).
Regarding Claim 3, Cabiri discloses the adjustable portion is rotationally displaceable with respect to the fixed portion in a single direction (Par. 31).
Regarding Claim 6, Cabiri discloses a syringe barrel (see generally 345 – not shown for Figs. 2), wherein the stopper is at least partially disposed within the syringe barrel.
Regarding Claim 13, Cabiri discloses the adjustable portion includes a first end attachable to the fixed portion (see Fig. 2A, 230 at the distal end), and a second end opposite the first end (i.e. the proximal end of 230), the spacer assembly further comprising a shim (240) releasably engageable (see e.g. Fig. 2C) with the second end of the adjustable portion (see via threads 229”).
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2010/0094253 (“Boyd”).
Regarding Claim 1, Boyd discloses a spacer assembly, comprising:
a stopper (11); and
a spacer (10, 14) attached to the stopper, the spacer comprising:
a fixed portion (10) fixedly connected to the stopper; and
an adjustable portion (14) axially displaceable with respect to the fixed portion (see Fig. 1, 2 in series).
Regarding Claim 2, Boyd discloses the adjustable portion is rotationally displaceable with respect to the fixed portion (Par. 61), and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion (see Figs. 1, 2 in series).
Regarding Claim 3, Boyd discloses the adjustable portion is rotationally displaceable with respect to the fixed portion in a single direction (see Fig. 1 – i.e. the adjustable portion cannot be rotated and advanced in the distal direction in Fig. 1)
Regarding Claim 6, Boyd discloses a syringe barrel (4), wherein the stopper is at least partially disposed within the syringe barrel (Fig. 1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 6, 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,549,044 (“Quinn”) in view of U.S. Publication No. 2008/0039789 (“Wyrick”).
Regarding Claim 1, Quinn recites a spacer assembly (see Clm. 14), comprising:
a stopper; and
a spacer attached to the stopper, the spacer, comprising:
a fixed portion (re: first spacer portion) connected to the stopper (re: “received within the stopper”); and
an adjustable portion (re: second spacer portion) axially displaceable with respect to the fixed portion (see Clm. 14).
While Quinn does not claim that the fixed portion is “fixedly” connected to the stopper, such a configuration is known in prior art spacers (see Fig. 6, 7 – Wyrick) wherein a stopper and fixed spacer portion are fixedly connected to one another via a threaded interconnection to permit them to move together and thereby would have been obvious to include in association with the invention of Quinn.
Regarding Claims 2, Quinn fails to claim that the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion. However, Wyrick discloses that such a rotational displacement translating axial displacement is a known means by which an adjustable spacer can be provided (see Fig. 7, 8 – Par. 76, 77) and therefore would have been an obvious modification to the invention of Quinn as claimed.
Regarding Claim 4, Quinn fails to claim that the spacer is threadably attached to the stopper. However, the use of such a threaded engagement is obvious (see Wyrick wherein 14 and 63 are threaded together to fix their position).
Regarding Claim 6, Quinn recites a syringe barrel (re: “container”), wherein the stopper is at least partially disposed within the syringe barrel.
Regarding Claim 14, Quinn recites (see Clm. 14) a drive assembly for a drug delivery system, the drive assembly comprising:
a plunger member configured to engage and move a stopper within a container, the plunger member having a first position and a second position axially spaced from the first position;
a biasing member configured to move the plunger member from the first position to the second position; and
an adjustable spacer positioned between the plunger member and the stopper, the adjustable spacer comprising:
a fixed portion; and
an adjustable portion axially displaceable with respect to the fixed portion.
Regarding Claims 15, Quinn fails to claim that the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion. However, Wyrick discloses that such a rotational displacement translating axial displacement is a known means by which an adjustable spacer can be provided (see Fig. 7, 8 – Par. 76, 77) and therefore would have been an obvious modification to the invention of Quinn as claimed.
Claim(s) 1, 2, 4, 6, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 12,053,620 (“Quinn ‘620”) in view of U.S. Publication No. 2008/0039789 (“Wyrick”)
Regarding Claim 1, Quinn recites (see Clm. 1 or 10) a spacer assembly, comprising:
a stopper (while not explicitly claimed obvious to include through the recitation of “configured to be received by a stopper”; and
a spacer attached to the stopper, the spacer comprising:
a fixed portion (first spacer portion) connected to the stoper; and
an adjustable portion (second spacer portion) axially displaceable with respect to the fixed portion.
While Quinn ‘620 does not claim that the fixed portion is “fixedly” connected to the stopper, such a configuration is known in prior art spacers (see Fig. 6, 7 – Wyrick) wherein a stopper and fixed spacer portion are fixedly connected to one another via a threaded interconnection to permit them to move together and thereby would have been obvious to include in association with the invention of Quinn ‘620.
Regarding Claims 2, Quinn ‘620 fails to claim that the adjustable portion is rotationally displaceable with respect to the fixed portion, and wherein rotational displacement of the adjustable portion axially displaces the adjustable portion with respect to the fixed portion. However, Wyrick discloses that such a rotational displacement translating axial displacement is a known means by which an adjustable spacer can be provided (see Fig. 7, 8 – Par. 76, 77) and therefore would have been an obvious modification to the invention of Quinn as claimed.
Regarding Claim 4, Quinn ‘620 fails to claim that the spacer is threadably attached to the stopper. However, the use of such a threaded engagement is obvious (see Wyrick wherein 14 and 63 are threaded together to fix their position).
Regarding Claim 6, Quinn ‘620 recites a syringe barrel (re: “container” – see Clm. 9 or 17), wherein the stopper is at least partially disposed within the syringe barrel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/04/2026
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