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 .
Response to Amendment
This office action is responsive to the amendment filed on 07/20/2026. As directed by the amendment: claims 24, 26-31, 35, 37, and 41 have been amended, claim 34 has been cancelled, and claim 44 has been added. Thus, claims 24-33 and 35-44 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112 rejection, minus the 112(b) rejection of claim 37 maintained below, set forth in the Non-Final Office Action mailed on 04/20/2026. The 112(f) interpretations are maintained.
Response to Arguments
Applicant’s arguments, see p.9 of “Remarks”, filed 07/20/2026, with respect to the 112(b) rejection of claim 40 have been fully considered and are persuasive. The 112(b) rejection of 04/20/2026 has been withdrawn.
Applicant’s arguments, see p.9-10 of “Remarks”, filed 07/20/2026, with respect to the 102 rejection have been fully considered and are persuasive. The 102 rejection of 04/20/2026 has been withdrawn.
Applicant’s arguments, see p.11-14 of “Remarks”, filed 07/20/2026, with respect to the rejection(s) of claim(s) the subject matter of claim 44 (previously claims 24, 25, 42, and 43) under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Avery.
Claim Objections
Claim 35 is objected to because of the following informalities:
Regarding claim 35, the phrase “each of the respective securing feature” in lines 2-3 should read “each of the respective securing features” for proper grammar,
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A fixing member in claims 24 and 44,
A plurality of circumferentially disposed securing features in claim 24,
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the fixing member in claims 24 and 44, the specification is referenced for the corresponding structure. Fig. 4a and page 24, line 9 discloses the fixing member as a clip component with an approximately U-like shape. Examiner will be interpreting it as such.
Regarding the plurality of circumferentially disposed securing features in claim 24, the specification is referenced for the corresponding structure. Figs. 1B-1C and page 23, lines 4-6 disclose the securing features as finger-like or tab-like structures. Examiner will be interpreting them as such.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 26-28, 37, and 43-44 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.
Regarding claim 26, the phrase “the fixing member has a main body” in line 1 renders the claim unclear as it is unclear whether this is a different main body or the aforementioned main body of the fixing member in line 21 of claim 24. Examiner is interpreting it as the same.
Regarding claim 27, the phrase “the width of a radial opening” in line 2 renders the claim indefinite because it is unclear whether this is different radial opening or the aforementioned radial opening of in line 2 of claim 27. Examiner is interpreting it as the same.
Claim 37 recites the limitation "the neck portion of the cartridge” in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the neck portion of the cartridge is introduced in claim 25 and claim 37 is only dependent upon claim 24.
Claim 43 recites the limitation "the main body of the cartridge" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the end opposite" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 28, this claim is rejected due to its dependency upon a rejected base claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 44 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avery et al. (U.S Patent Pub. No. 20130204187 A1, “Avery”).
Regarding claim 44, Avery discloses (Claim 44) a drug delivery device (100 in Fig. 1A), comprising:
a cartridge assembly (700 and 704 in Fig. 14A-14B), comprising:
a cartridge (704 in Fig. 14A-14B) containing a drug (see Abstract), the cartridge (704) comprising a dispensing end (distal end of 704 in Fig. 14A-14B);
a cartridge holder (700), the cartridge holder (700) defining an interior cartridge holding section (interior cavity of 700 in Fig. 14B); where the cartridge (704) is arranged within the cartridge holding section (interior cavity of 700, see Fig. 14B); and
a fixing member (702, examiner notes this limitation is being interpreted under 112(f) as a clip-like component with a substantially U-shape, see Fig. 14A and para. 0040),
wherein the fixing member (702) comprises a fixing surface (distal surface of 702), which is arranged to abut a cartridge surface (proximal surface of 719 in Fig. 14B) of the cartridge (704, see at least Fig. 14B for abutment limitation, see annotated Avery drawing 1 below for fixing surface clarity, see para. 0207), wherein the cartridge surface (proximal surface of 719 in Fig. 14B) is a proximal surface which faces away from the dispensing end (distal end of 704) of the cartridge (704, see Fig. 14B and annotated Avery drawing 1 below and para. 0207), and wherein the cartridge surface (proximal surface of 719 in Fig. 14B) is arranged between the dispensing end (distal end of 704) of the cartridge (704) and the end (proximal end of 704) opposite of the dispensing end (distal end of 704, see Fig. 14B and annotated Avery drawing 1 below), and
wherein the fixing member (702) comprises a securing surface (radial surface of 702 in Fig. 14B) which is arranged to abut a holder surface (717 in Fig. 14B) of the cartridge holder (700) to prevent removal of the cartridge (704) from the cartridge holder (700) such that the cartridge (704) is permanently secured in the cartridge holder (700, see para. 0158 and see Fig. 14B and para. 0207), and wherein the holder surface (717) is a distal surface of the cartridge holder (700, see Figs. 14B and see annotated Avery drawing 1 below for exemplary embodiment of 700 and 704, examiner notes the distal surface is being
PNG
media_image1.png
689
830
media_image1.png
Greyscale
interpreted as a surface located in the distal portion of the device); and
a housing (102 in Fig. 1A) to which the cartridge assembly (700 and 704 in Fig. 14) is secured (see para. 0089); and
wherein the cartridge (704) has a head portion (ferrule of 704 in Fig. 14B), a main body portion (body of 704), and a neck portion (neck of 704, see annotated Avery 2 drawing below for head, main body, and neck), wherein the neck portion (neck of 704) is arranged between the head portion (ferrule of 704) and the main body portion (body of 704) and the neck portion (neck of 704) has a reduced diameter as compared to the head portion (ferrule of 704, see annotated Avery drawing 2 below), wherein the cartridge surface (proximal surface of 719) delimits the head portion (ferrule of 704) proximally (see Fig. 14B and annotated Avery drawing 2 below for portion
PNG
media_image2.png
607
780
media_image2.png
Greyscale
limitations),
PNG
media_image3.png
689
1014
media_image3.png
Greyscale
wherein the cartridge holder (700) has a first region in which the head portion (ferrule of 704) of the cartridge (704) is arranged and a second region that is axially offset from the first region in a proximal direction (see annotated Avery drawing 2 above), and
wherein the fixing surface (distal surface of 702) of the fixing member (702) is arranged in the first region (see annotated Avery drawing 2 above), wherein the main body portion (body of 704) of the cartridge (704) is arranged in the second region (see annotated Avery drawing 2 above), and wherein the securing surface (radial edge of 702) is arranged in the second region (see annotated Avery Drawing 2 above – as annotated above, the first region extends to the distal surface of the fixing member 702 and thus includes the fixing surface whereas the second region extends from the first region proximally and thus includes at least a portion of the radial surface of the fixing member 702 and thus the securing surface).
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 24-26, 29-30, 35, 37, and 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 9, and 10-13 of U.S. Patent No. 12186537 in view of Avery et al. (U.S Patent Pub. No. 20130204187 A1, “Avery”), see Table 1 for mapping of the claims.
Table 1 :
Instant Application (18962038) Claims
Reference Application (17258699) Claims
24
1
25
12
26
12
29
9
30
10
35
2
37
4
40
5
41
11
42
12
43
13
Instant Application Claim 24 recites a drug delivery device comprising a cartridge assembly. Reference Application Claim 1 recites a cartridge assembly. The instant application claim 24 differs from the reference application claim 1 only in reciting a drug delivery device comprising a housing to which the cartridge assembly is secured.
Avery discloses a cartridge assembly (104, 119 in Fig. 1A-1B) comprising a cartridge (119) and a cartridge holder (104), wherein a drug delivery device (100 in Fig. 1A) comprises said cartridge assembly (104, 119) and a housing (102 in Fig. 1A) to which the cartridge assembly (104, 119) is secured (see para. 0089).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge assembly taught by the reference application to be used by a drug delivery device comprising a housing to which the cartridge assembly is secured as taught by Avery. Avery teaches that cartridge assemblies are well known assemblies used in conjunction with drug delivery devices when the drug delivery device is reusable (see para. 0003). It is well known practice in the art to disconnect the cartridge holder from the drug delivery device, replace the empty cartridge, and secure the assembly back to the drug delivery device for reuse (see para. 0003).
The remaining instant application claims have the same scope as the cited reference application claims with the exception of the drug delivery device limitation discussed above that is rendered obvious in view of Avery.
Allowable Subject Matter
Claims 24-25, 29-30, 35, and 40-42 would be allowable if rewritten and amended to overcome the double patenting rejections, set forth in this Office Action, or with the filing of a terminal disclaimer.
Claims 31-33, 36, 38-39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 26-28, 37, and 43 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and by overcoming the double patent rejection above.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Avery et al. (U.S Patent Pub. No. 20130253432 A1, “Avery 2”) and Bar-el et al. (W.O Patent Pub. No. 2019126421 A1, “Bar-el”):
Bar-el discloses a cartridge assembly comprising a cartridge door (26) interpreted as the holder, a cartridge (28), and an adapter collar (30 in Fig. 4-6, see para. 0032 and 0034). The adapter collar (30) is configured to engage with the cartridge (28) and the interior pathway (26b) of the cartridge door (26) to stabilize the cartridge (28) within the pathways (26b, see para. 0034). The collar (30) comprises a plurality of circumferentially disposed deflectable fingers (36 in Fig. 6) oriented adjacent slots (32a in Fig. 6) between adjacent fingers (36), wherein the slots (32a) receive the annular lip segments (40) of the cartridge door (26) to mount the collar (30) and thus the cartridge (28) to the cartridge door (26b) for centering the cartridge and protecting a needle tip (see para. 0034 and 0044). However, Bar-el's collar (30) does not anticipate the fixing member of the claimed invention as it is not disclosed primarily for retaining the cartridge within the cartridge holder nor are the plurality of circumferentially disposed fingers (36) disclosed as each defining a section of a securing surface that abuts with the cartridge door. Rather, the fingers (36) are configured to engage with the cartridge (28) for covering the piercing needle (26c, see para. 0037). There is no teaching reference to include a fixing member comprising a plurality of circumferentially disposed features as interpreted under 112(f) as a plurality of circumferentially disposed finger-like or tab-like structures, wherein each feature defines one section of the securing surface and the features extend axially and radially away from the fixing member body.
Avery 2 discloses a cartridge assembly (see Fig. 12) comprising a cartridge holder (820), a cartridge (810), and a locking mechanism (800), wherein the locking mechanism (800) operates in a similar manner as the fixing member to contact both the cartridge (810) and cartridge holder (820) for preventing removal of said cartridge from said holder (see para. 0080-0081). The locking mechanism (800) comprises a securing surface (832 in Fig. 12) disposed on an external ledge (830) which is a circumferentially disposed ledge abutting a holder surface in the groove (840 in Fig. 12) of the cartridge holder (820) for preventing removal of said cartridge from the said holder (see para. 0080-0081). While Avery 2 discloses a circumferentially disposed securing feature comprising the securing surface, Avery 2 fails to disclose a plurality of said securing features as interpreted under 112(f) as a plurality of circumferentially disposed finger-like or tab-like structures. There is no reference to modify Avery 2 to be a plurality of securing features.
Therefore, there is no reference that discloses or teaches the plurality of circumferentially disposed securing features as interpreted under 112(f) and as claimed in claim 24.
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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, Bhisma Mehta can be reached on (571) 272-3383. 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.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
