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 .
Acknowledgments
In the reply, filed on July 15, 2026, Applicant amended claims 16, 21, and 27-30.
Applicant cancelled claim 17.
In the non-final rejection of May 19, 2026, Examiner objected to the Abstract. Applicant amended the Abstract; however, Applicant did not address all of the objections. Objection is maintained.
Examiner objected to claims 16-17 and 27-30. Applicant amended claims 16 and 27-30, and cancelled claim 17; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 16-26 and 28-30 under 35 U.S.C. 112(b). Applicant amended claims 16 and 28, and cancelled claim 17; however, Applicant did not address all of the rejections. Rejection is maintained.
Specification
The abstract of the disclosure is objected to because:
In line 10, “the proximal end (106)” should be changed to “the proximal end (106) of the housing (104)”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 16 and 29 are objected to because of the following informalities:
In regards to claim 16, lines 11-12, “the proximal end” should be changed to “the proximal end of the housing”.
In regards to claim 29, line 2, “the step of inserting” should be changed to “the inserting”.
Appropriate correction is required.
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.
Claims 16, 18-26, and 28-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 16, lines 10-11 recite: “wherein the sealable portion is capable of sealing one or more components of the medicament delivery device”; however, such is new matter not described in the Specification. Claims 18-26 and 28-30 are rejected by virtue of being dependent upon claim 16.
In regards to claim 28, lines 5-6 recite: “wherein the sealable portion is capable of sealing one or more components of the medicament delivery device”; however, such is new matter not described in the Specification. Claims 29-30 are rejected by virtue of being dependent upon claim 28.
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 16, 18-26, and 28-30 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.
In regards to claim 16, lines 10-11 recite: “one or more components” of the medicament delivery device. It is unclear which components are included in or meant by “one or more components”. Claims 18-26 and 28-30 are rejected by virtue of being dependent upon claim 16.
In regards to claim 28, lines 5-6 recite: “one or more components” of the medicament delivery device. It is unclear which components are included in or meant by “one or more components”. Claims 29-30 are rejected by virtue of being dependent upon claim 28.
In regards to claim 28, line 8 recites: assembling the subassembly “according to claim 16”. Claim 28, line 3 previously introduces “a subassembly”. It is unclear why the subassembly “according to claim 16” is being assembled in claim 28, line 8, instead of the subassembly introduced in claim 28, line 3. Claims 29-30 are rejected by virtue of being dependent upon claim 28.
In regards to claim 30, line 4 recites “the sealed distal end”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 30 depends upon claim 29, which depends upon claim 28. Claim 28, line 4 recites: “the distal end comprises a sealable portion”. It is unclear whether the two terms are the same or different.
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.
Claims 16 and 18-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adlon et al (US 9,821,118).
In regards to claim 16, Adlon et al teaches a subassembly (Figures 4A-4B) of a medicament delivery device, the subassembly comprising:
a housing (20) configured to contain a medicament container structure from which a medicament is expelled during use of the medicament delivery device (Figure 4A), the housing having a proximal end (at 25A) and a distal end (at 24B)
a drive assembly (30) comprising a plunger rod (31) at a proximal end of the drive assembly, the plunger rod being configured to, upon activation, apply an activating force on the medicament container structure for expelling the medicament from the medicament delivery device (Figure 4A), wherein the proximal end of the housing comprises an opening (at 25A), and the distal end comprises a sealable portion (50), where the sealable portion is capable of sealing one or more components of the medicament delivery device (Figure 4A), wherein the drive assembly is insertable into the housing at the proximal end to form the subassembly (Figure 4B to Figure 4A)
wherein the housing comprises an envelope surface (20) extending axially from the distal end to the proximal end of the housing, the sealable portion being integrally formed with the envelope surface (Figure 4A)
In regards to claim 18, Adlon et al teaches wherein the sealable portion is formed by a removable cap (50).
In regards to claim 19, Adlon et al teaches wherein a distal end of the drive assembly is arranged at the distal end of the housing when the drive assembly is inserted into the housing (Figure 1B).
In regards to claim 20, Adlon et al teaches wherein the housing is a cylindrical housing (20) forming a hollow housing structure (20).
In regards to claim 21, Adlon et al teaches wherein the housing comprises an inspection portion (at 25A), wherein the inspection portion is configured to assist a user in viewing the medicament (Figure 4A).
In regards to claim 22, Adlon et al teaches wherein the inspection portion is an elongated inspection portion (at 25A) extending along an axial direction of the housing, wherein a proximal end of the inspection portion is arranged closer to the proximal end of the housing compared to the distal end of the housing (Figure 4B).
In regards to claim 23, Adlon et al teaches wherein the sealable portion comprises a connector portion (54A) at a surface facing the drive assembly.
In regards to claim 24, Adlon et al teaches wherein the housing comprises a drive assembly guiding structure (22A), the drive assembly guiding structure extending in an axial direction on an inner surface of the housing (Figure 4B).
In regards to claim 25, Adlon et al teaches wherein the drive assembly comprises a biasing member (40) connected to the plunger rod.
In regards to claim 26, Adlon et al teaches wherein the biasing member is arranged to generate the activating force on the plunger rod (Figure 4A).
In regards to claim 27, Adlon et al teaches a method of assembling a subassembly of a medicament delivery device (Figures 4A-4B), wherein the subassembly comprises a housing (20) configured to contain a medicament container structure from which a medicament is expelled during use of the medicament delivery device (Figure 4A), the housing having a proximal end (at 25A), a distal end (at 24B), a sealable portion (50), an envelope surface (20) extending axially from the distal end to the proximal end of the housing, the sealable portion being integrally formed with the envelope surface (Figure 4A), and a drive assembly (30) configured to generate an activating force on the medicament container structure for expelling the medicament when the medicament container structure is arranged in the medicament delivery device (Figure 4A), the method comprising:
inserting the drive assembly into the housing through an opening (at 25A) of the housing at the proximal end (Figure 4B to Figure 4A)
moving the drive assembly in a distal direction within the housing towards the distal end of the housing (Figure 1B)
In regards to claim 28, Adlon et al teaches a method of assembling a medicament delivery device (Figures 4A-4B), the medicament delivery device comprising:
a subassembly comprising a housing (20) having a proximal end (at 25A) and a distal end (at 24B), wherein the proximal end of the housing comprises an opening (at 25A) and the distal end comprises a sealable portion (50), where the sealable portion is capable of sealing one or more components of the medicament delivery device (Figure 4A), the subassembly further comprising a drive assembly (30), and a medicament container structure (110/120) comprising a medicament (column 4, lines 38-45), wherein the method comprises:
assembling the subassembly according to claim 16 (Figure 4B to Figure 4A)
inserting the medicament container structure into the housing through the opening of the housing at the proximal end (Figure 4B to Figure 4A)
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.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Adlon et al, as applied to claim 28 above, and further in view of Iio et al (US 8,801,679).
In regards to claim 29, Adlon et al teaches wherein the medicament delivery device further comprises an expulsion member (150), wherein the step of inserting the medicament container structure into the housing is preceded by a step of:
thereby forming a medicament expulsion arrangement (110/120/150) (Figure 4B)
wherein the medicament container structure is inserted into the housing by inserting the medicament expulsion arrangement into the housing through the opening of the housing at the proximal end (Figure 4B to Figure 4A)
Adlon et al teaches the expulsion member (150) is affixed to the medicament container structure (110/120) (column 10, lines 28-30); however, Adlon et al is silent about inserting the medicament container structure into the expulsion member by moving the medicament container structure in a proximal direction relative to the expulsion member. Iio et al teaches a method of assembling a medicament delivery device (Figures 3-5), wherein the method comprises a step of: inserting a medicament container structure (15) into an expulsion member (14) by moving the medicament container structure in a proximal direction relative to the expulsion member (Figures 3-4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Adlon et al, with inserting the medicament container structure into the expulsion member by moving the medicament container structure in a proximal direction relative to the expulsion member, as taught by Iio et al, as such will support the medicament container structure and prevent the medicament container structure from falling out of the expulsion member (column 6, lines 27-30).
In regards to claim 30, in the modified method of Adlon et al and Iio et al, Adlon et al teaches moving the medicament expulsion arrangement in a distal direction within the housing towards the sealed distal end of the housing (Figure 4B to Figure 4A).
Response to Amendment
The amendment to the claims filed on July 15, 2026, does not comply with the requirements of 37 CFR 1.121(c) because claims 1-15 are missing from the claim listing. While claims 1-15 are understood as cancelled, said claims should still be listed in the claim listing with the status (Cancelled).
Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Response to Arguments
Applicant's arguments filed July 15, 2026, have been fully considered but they are not persuasive:
In regards to claim 16, Applicant argued: Applicant submits that Adlon instead discloses, at most, a distinct sealable portion and a distinct envelope surface capable of being assembled. The sealable portion of Adlon disclosed by part 50 and the envelope surface disclosed by part 20 are separate, distinctive components. The sealable portion of Adlon is not integral with the envelope surface, but rather, as shown by Fig. 4B, the sealable portion twists into the envelope surface of part 20. In contrast, amended claim 16 recites that the sealable portion and the envelope surface are integrally formed. Thus, Adlon fails to disclose the housing comprises a sealable portion and an envelope surface, much less that the envelope surface extends axially from the distal end to the proximal end of the housing, much less that the sealable portion and the envelope surface are integrally formed, much less all of the features in combination with the remaining features of claim 16 (Remarks, page 9). Examiner disagrees. Adlon et al teaches wherein the housing (20) comprises an envelope surface (20) extending axially from the distal end (at 24B) to the proximal end (at 25A) of the housing, the sealable portion (50) being integrally formed with the envelope surface (Figure 4A). The term “integrally” means “formed as a unit with another part” (https://www.merriam-webster.com/dictionary/integrally). Adlon teaches that 50 is formed as a unit (Figure 4A) with 20.
In regards to claim 27, Applicant argued: Independent claim 27, as amended, includes features consistent with those discussed above with respect to claim 16. As a result, Applicant respectfully requests that the rejection to claim 27 be withdrawn for consistent reasons (Remarks, page 10). Examiner disagrees and maintains the rejection of claim 27 for the same reasons as provided above with respect to claim 16.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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