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 .
Filing Receipt
A new filing receipt has been generated dated 07/22/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the interaction of the bump 1516 with the interior of the shell walls 1512 in order to provide haptic feedback as described in the specification. Specifically, Fig 15A shows the bump 1516 within the syringe barrel 1504. However, this configuration is not in any way structured to interact with the shell walls 1512. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The previous objection to claim 24 (the claim states that the syringe barrel includes a window; however, both the drawings and the specification refer to the window 1410 being in the shell housing 1408) has been withdrawn in light of the cancellation of the claim in the amendment filed 07/17/2026.
The previous objection to claim 28 (these claims are duplicate claims) has been withdrawn in light of the cancellation of the claim in the amendment filed 07/17/2026.
The previous objection to claim 27 (both claims depend from claim 3 which has been cancelled) has been withdrawn in light of the amendment of the claim to depend from claim 23 the claim in the amendment filed 07/17/2026.
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.
Claims 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 14 and 20-21 of U.S. Patent No. 10,688,289 (“the ‘289 patent”) in view of US Pub. No. 2014/0074140 to Johnson et al. (“Johnson”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are a patentably non-distinct subcombination of the combination claimed in the ‘289 patent. See Table 1 below.
Claim Limitation
The instant claims
The ‘289 patent claims
An inflation and deflation device comprising:
21
1; 14, 20
a housing;
21
1 (a housing would be an obvious incorporation into the claim and is recited in claim 4); 14, 20
a syringe barrel,
21
1; 14, 20
having a fluid connection port,
21 (claims fluid connection port; 1 fluid connection port is a broader recitation)
1; 14, 20 (claims second fluid connection port)
the fluid connection port configured to be in fluid communication with a second fluid connection port on a second device;
21
1; 14, 20 (second fluid connection port in fluid connection with first fluid connection port of the delivery device)
the housing comprising a window configured to allow visualization of fluid in the syringe barrel
21
Obvious to incorporate in light of Johnson (see rejection below)
a plunger arranged to reversibly move a length within the syringe barrel; and
21
1; 14, 20
a locking mechanism configured to limit the length the plunger can depress within the syringe barrel.
21
1; 14, 20
wherein the locking mechanism comprises a pair of pawls configured to extend outward and physically interface with the housing
22
4; 21
wherein the second device is an applicator device comprising an expandable member.
23
1; 14
Table 1
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 30 recites the limitation “the locking mechanism uses a structure akin to a ball-point pen so that depression of the plunger past a predetermined distance leads to a haptic click.” First, it is assumed this claim limitation and related disclosure in the specification is referring to the extension and retraction mechanism of click pens and not the structure of the ball point pen tip. This imprecision of the claim/specification language itself already leads one skilled in the art to make an assumption about the structural mechanism referenced. Second, the claims cover an inflation and deflation device not a writing instrument. Specifically, the locking mechanism in the embodiment of Fig. 15A (the same embodiment with the disclosure of “a structure akin to a ball-point pen”) discloses a longitudinally reciprocating locking mechanism. However, a typical click pen makes the haptic clip due to rotation of the ink barrel and cam body. See USPN 3,205,863. There is no teaching of rotation of the locking mechanism in the embodiment of Fig. 15A. Further, there is no one standard click pen mechanism and multiple companies have developed different structural mechanisms for the extension and retraction and thereby click of the ink cartridge. Therefore, the breadth of the claims exceeds the scope of the enablement provided, requiring undue experimentation to fit an undisclosed rotating or other structure causing a haptic click into a longitudinally reciprocating mechanism. See MPEP 2164.04
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-23, 25, 27, 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2014/0074140 to Johnson et al. (“Johnson”).
Regarding claim 21, Johnson discloses an inflation and deflation device comprising a housing (860,960) a syringe barrel (880,990) having a fluid connection port (884,984), the fluid connection port configured to be in fluid communication with a second fluid connection port on a second device; a plunger (900,1000) arranged to reversibly move a length within the syringe barrel, and a locking mechanism (1006,1030) configured to limit the length the plunger can depress within the syringe barrel. See the embodiment of Figs. 18-21E.
Johnson meets the claim limitations as described above but Johnson does not teach a window in the embodiment of Figs. 18-21E. However, Johnson discloses a window (862) in the housing (860) of the embodiment of Figs. 13-17C.
At the time of filing, it would have been obvious to incorporate the housing of the embodiment of Figs. 13-17C into the embodiment of Figs. 18-21E. Having the housing extend to incorporate the syringe while still including a window to see the contents of the syringe would provide the embodiment of Figs. 18-21E with the protective outer covering of the housing and still enable visualization of the syringe contents. This would have been done in order to enhance the connection of the syringe to the locking mechanism.
Regarding claim 22, Johnson discloses the device of claim 21 and further teaches wherein the locking mechanism comprises a pair of pawls (1006) configured to extend outward and physically interface with the housing (860,960) as best seen in at least FIGS. 18-21 and as set forth in paras [0139-0156].
Regarding claim 23, Johnson discloses the device of claim 21 and further teaches wherein the second device is an applicator device (10) comprising an expandable member (14).
Regarding claims 25-26, Johnson discloses the device of claim 21 and further teaches that lock mechanism includes sawteeth (1006). The sawteeth (1006) are capable of making a clicking noise and feeling as the teeth transfer over pawl (1014). Therefore, at the time of filing it would have been obvious for one skilled in the art to construct the locking mechanism of Johnson so that the sawteeth click over the pawl in order to provide the user with a tactile sensation of increments of injection.
Regarding claims 27, Johnson discloses the device of claim 21 and further teaches wherein the device is configured to deliver fluid to expand the expandable member of the applicator device at a force of from about two to about 16 atmospheres. See para. [0074] 1 teaching the inflation of the dilator to a range of 10-12 atmospheres.
Regarding claim 29, Johnson discloses the device of claim 27 and further teaches wherein the device is configured to deliver fluid to expand the expandable member of the applicator device at a force of twelve atmospheres. See para. [0074] teaching the inflation of the dilator to a range of 10-12 atmospheres.
Response to Arguments
Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive. Applicant argues that one skilled in the art would not be motivated to incorporate the window of the embodiment of Johnson Figs. 13-17C to the embodiment of Johnson Figs. 18-21A since the housing in the embodiment of Figs. 18-21A specifically Fig. 21A does not cover the majority of the syringe barrel 980. See remarks filed 07/17/2026 pages 7-9.
However, applicant is not arguing the rejection as presented. The rejection of the claims presented in the non-final office action mailed 01/22/2026 page 9, incorporates the housing with window as shown in the embodiment of Figs. 13-17C into the embodiment of Figs. 18-21E. The motivation provided to incorporate the housing with window was provided stating, “[h]aving the housing extend to incorporate the syringe while still including a window to see the contents of the syringe would provide the embodiment of Figs. 18-21E with the protective outer covering of the housing and still enable visualization of the syringe contents. This would have been done in order to enhance the connection of the syringe to the locking mechanism.” Therefore, applicant’s arguments are not persuasive since the arguments do not address the combination as set forth in the rejection.
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 CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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, Eileen Lillis can be reached at 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
1 This paragraph number has been corrected to identify the correct paragraph number in the publication. This correction does not amount to a new grounds of rejection since the rejection itself relies on the same teaching as in the non-final office action mailed 01/22/2026.
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