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 without traverse of Invention I and Species II(a) in the reply filed on 07/31/2026 is acknowledged.
Claims 29-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2026.
Claim Objections
Claims 16-28 are objected to because of the following informalities.
Claim 16 should read --A housing of a drug delivery device, the housing comprising:
a first housing component configured to accommodate a cartridge filled with a medicament, the first housing component comprising a first connecting end;
a second housing component configured to accommodate a drive mechanism of the drug delivery device, the second housing component comprising a second connecting end;
an insert provided on one of the first connecting end and the second connecting end;
a receptacle provided on an other one of the first connecting end and the second connecting end, wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component;
a threaded connection to mutually connect the first connecting end and the second connecting end, the threaded connection comprising a helical thread provided on the insert and a helical counter thread complementary shaped to the helical thread and provided in the receptacle;
a rotation lock configured to impede screwing and/or unscrewing of the first housing component and the second housing component when the housing is in a final assembly configuration, the rotation lock comprising a locking structure on the first housing component and a counter locking structure complementary shaped to the locking structure and provided on the second housing component.—
Claim 17 should read --The housing according to claim 16, wherein the locking structure and the counter locking structure are mutually engageable through a twisting helical motion of the first housing component relative to the second housing component upon reaching or during
Claim 18 should read --The housing according to claim 16, wherein the locking structure comprises a toothed profile complementary shaped to a counter toothed profile of the counter locking structure, and wherein one of the toothed profile and the counter toothed profile comprises at least one locking tooth extending in the longitudinal direction, and wherein an other one of the toothed profile and the counter toothed profile comprises at least one locking recess complementary shaped to the locking tooth.—
Claim 19 should read --The housing according to claim 18, wherein the at least one locking tooth comprises an asymmetric profile with regard to a circumferential direction of the first housing component or the second housing component.—
Claim 24 should read --The housing according to claim 23, wherein one of the proximally facing stop face and the distally facing counter stop face is a longitudinal end face of one of the first housing component and the second housing component, and wherein an other one of the proximally facing stop face and the distally facing counter stop face is provided on a stepped portion protruding radially from a sidewall of an other one of the first housing component and the second housing component.--
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 as follows.
“drive mechanism” in Claim 16, where the generic placeholder is “mechanism”, the functional language is “drive”, and sufficient modifying structure is not provided; instant application Page 3 describes the drive mechanism as a piston rod, providing sufficient modifying structure
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.
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 21 & 26-28 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.
As to Claim 21, the limitation “a flank angle of the first tooth flank is smaller than a flank angle of the second tooth flank” is indefinite, since the limitation is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structure, lines, planes, surfaces, etc, which define the respective flank angles. As such, it is not clear how to determine the relative sizes of each flank angle. For the purpose of examination, the respective angles will be interpreted as being defined by the surface of each respective flank with a plane perpendicular to the longitudinal direction.
As to Claim 26, the terms “mechanical coding” and “mechanical counter coding” are indefinite in light of the specification. Instant application Page 38 describes the mechanical coding 150 as being part of the helical thread 120, and the mechanical counter coding 250 as being part of the helical counter thread 220. However, the terms are presented in the claim as though the respective codings are separate from the respective threads, rendering the claim indefinite. For the purpose of examination, the claim will be interpreted where the helical thread comprises a mechanical coding, and the helical counter thread comprises a mechanical counter coding.
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 16-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanofi (EP3597239A1).
As to Claim 16, Sanofi teaches a housing (10/300/350) of a drug delivery device (Figures 14/15), the housing (10/300/350) comprising:
a first housing component (300) configured to accommodate (Paragraph 0055) a cartridge (301) filled with (Paragraph 0075) a medicament (307), the first housing component (300) comprising a first connecting end (the bottom of 300, as viewed in Figure 3A);
a second housing component (10/350; Paragraph 0103) configured to accommodate a drive mechanism (Paragraph 0104) of the drug delivery device (Figures 14/15), the second housing component (10/350) comprising a second connecting end (the top of 350, as viewed in Figure 3A);
an insert (320) provided on (as shown in Figure 3A) one (the bottom of 300, as viewed in Figure 3A) of the first connecting end (the bottom of 300, as viewed in Figure 3A) and the second connecting end (the top of 350, as viewed in Figure 3A);
a receptacle (the volume within 350, as viewed in Figure 3A) provided on (as shown in Figure 3A) the other one (the top of 350, as viewed in Figure 3A) of the first connecting end (the bottom of 300, as viewed in Figure 3A) and the second connecting end (the top of 350, as viewed in Figure 3A), wherein the insert (320) is insertable into (as shown in Figure 3A) the receptacle (the volume within 350, as viewed in Figure 3A) along a longitudinal direction (up and down, as viewed in Figure 3A) for mutually fastening (as shown in Figures 3A-C) the first housing component (300) and the second housing component (10/350);
a threaded connection (327/351, replaced by threads, as described in Paragraph 0075) to mutually connect (as shown in Figures 3A-C) the first connecting end (the bottom of 300, as viewed in Figure 3A) and the second connecting end (the top of 350, as viewed in Figure 3A), the threaded connection (327/351, replaced by threads, as described in Paragraph 0075) comprising a helical thread (327, modified to be a thread, as described in Paragraph 0075) provided on (as shown in Figures 3A-C) the insert (320) and a helical counter thread (351, modified to be a thread, as described in Paragraph 0075) complementary shaped to (one of ordinary skill in the art would conclude threads and counter threads need to be helical and complementary in order to work with each other) the helical thread (327, modified to be a thread, as described in Paragraph 0075) and provided in (as shown in Figures 3A-C) the receptacle (the volume within 350, as viewed in Figure 3A);
a rotation lock (329/353) configured to impede screwing and/or unscrewing (via the angled ramps interacting with each other, as shown in Figures 3A-C) of the first housing component (300) and the second housing component (10/350) when the housing (10/300/350) is in a final assembly configuration (Figure 9), the rotation lock (329/353) comprising a locking structure (329) on (as shown in Figures 3A-C) the first housing component (300) and a counter locking structure (353) complementary shaped to (as shown in Figures 3A-C) the locking structure (329) and provided on (as shown in Figures 3A-C) the second housing component (10/350).
As to Claim 17, Sanofi teaches all the limitations of Claim 16, and continues to teach the locking structure (329) and the counter locking structure (353) are mutually engageable through a twisting helical motion (as shown in Figures 3A-C) of the first housing component (300) relative to (as shown in Figures 3A-C) the second housing component (10/350) upon or during reaching the final assembly configuration (Figure 9).
As to Claim 18, Sanofi teaches all the limitations of Claim 16, and continues to teach the locking structure (329) comprises a toothed profile (329) complementary shaped to (as shown in Figures 3A-C) a counter toothed profile (353) of the counter locking structure (353), and wherein one (see Figures 3A-C below) of the toothed profile (329) and the counter toothed profile (353) comprises at least one locking tooth (see Figures 3A-C below) extending (as shown in Figures 3A-C) in the longitudinal direction (up and down, as viewed in Figure 3A), and wherein the other one (see Figures 3A-C below) of the toothed profile (329) and the counter toothed profile (353) comprises at least one locking recess (see Figures 3A-C below) complementary shaped to (as shown in Figures 3A-C) the locking tooth (see Figures 3A-C below).
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Sanofi Figures 3A-C, Modified by Examiner
As to Claim 19, Sanofi teaches all the limitations of Claims 16 & 18, and continues to teach the at least one locking tooth (see Figures 3A-C in the Claim 18 rejection above) comprises an asymmetric profile (as shown in Figures 3A-C) with regard to a circumferential direction (left and right, as viewed in Figure 3A) of the first housing component (300) or second housing component (10/350).
As to Claim 20, Sanofi teaches all the limitations of Claims 16 & 18, and continues to teach the at least one locking tooth (see Figures 3A-C in the Claim 18 rejection above) comprises a first tooth flank (see Figures 3A-C in the Claim 18 rejection above) facing in a first circumferential direction (to the right, as viewed in Figure 3C) and a second tooth flank (see Figures 3A-C in the Claim 18 rejection above) facing in a second circumferential direction (to the left, as viewed in Figure 3C) opposite the first circumferential direction (to the right, as viewed in Figure 3C), and wherein the first tooth flank (see Figures 3A-C in the Claim 18 rejection above) distinguishes from (as shown in Figures 3A-C) the second tooth flank (see Figures 3A-C in the Claim 18 rejection above) by at least one of a circumferential length (Figure 3C shows the first tooth flank circumferential length is larger than the second tooth flank circumferential length) and a flank angle (Figure 3C shows the first tooth flank flank angle as different than the second tooth flank flank angle).
As to Claim 21, Sanofi teaches all the limitations of Claims 16, 18 & 20, and continues to teach a circumferential length (the length from the peak of the locking tooth extending to the right to the second tooth flank) of the first tooth flank (see Figures 3A-C in the Claim 18 rejection above) is larger than a circumferential length (the length from the peak of the locking tooth extending to the left to the first tooth flank) of the second tooth flank (see Figures 3A-C in the Claim 18 rejection above), and wherein a flank angle of the first tooth flank (see Figures 3A-C in the Claim 18 rejection above) is smaller than a flank angle of the second tooth flank (see Figures 3A-C in the Claim 18 rejection above). Figures 3A-C show the first tooth flank flank angle as being smaller than the second flank flank angle.
As to Claim 22, Sanofi teaches all the limitations of Claims 16 & 18, and continues to teach the toothed profile (329) comprises a number of locking teeth and locking recesses in an alternating arrangement (as shown in Figures 3A-C) along a circumference (left and right, as viewed in Figure 3A) of the first housing component (300).
As to Claim 23, Sanofi teaches all the limitations of Claim 16, and continues to teach the first housing component (300) comprises a proximally facing (down, as viewed in Figure 3B) stop face (see Figures 3A-C in the Claim 18 rejection above) provided with (as shown in Figures 3A-C) a toothed profile (329), and wherein the second housing component (10/350) comprises a distally facing (up, as viewed in Figure 3B) counter stop face (see Figures 3A-C in the Claim 18 rejection above) provided with (as shown in Figures 3A-C) a counter toothed profile (353).
As to Claim 24, Sanofi teaches all the limitations of Claims 16 & 23, and continues to teach one (the stop face, as shown in Figures 3A-C) of the proximally facing (down, as viewed in Figure 3B) stop face (see Figures 3A-C in the Claim 18 rejection above) and the distally facing (up, as viewed in Figure 3B) counter stop face (see Figures 3A-C in the Claim 18 rejection above) is a longitudinal end face (the end face of 300 facing down, as viewed in Figures 3A-C) of one (300) of the first housing component (300) and the second housing component (10/350), and wherein the other one (the counter stop face, as shown in Figures 3A-C) of the proximally facing (down, as viewed in Figure 3B) stop face (see Figures 3A-C in the Claim 18 rejection above) and the distally facing (up, as viewed in Figure 3B) counter stop face (see Figures 3A-C in the Claim 18 rejection above) is provided on (as shown in Figures 3A-C) a stepped portion (see Figures 3A-C in the Claim 18 rejection above) protruding radially from (left and right, as viewed in Figures 3A-C) a sidewall (see Figures 3A-C in the Claim 18 rejection above) of the other one (10/350) of the first housing component (300) and the second housing component (10/350).
As to Claim 25, Sanofi teaches all the limitations of Claims 16 & 23, and continues to teach at least one (the counter stop face) of the proximally facing (down, as viewed in Figure 3B) stop face (see Figures 3A-C in the Claim 18 rejection above) and the distally facing (up, as viewed in Figure 3B) counter stop face (see Figures 3A-C in the Claim 18 rejection above) is located on an annular rim (the stepped portion shown in Figures 3A-C in the Claim 18 rejection above) protruding radially from (left and right, as viewed in Figures 3A-C) a sidewall (see Figures 3A-C in the Claim 18 rejection above) of the insert or receptacle (the volume within 350, as viewed in Figure 3A).
As to Claim 26, Sanofi teaches all the limitations of Claim 16, and continues to teach a mechanical coding (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) provided on (as shown in Figures 3A-C) the insert (320) and comprising a mechanical counter coding (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) provided in (as shown in Figures 3A-C) the receptacle (the volume within 350, as viewed in Figure 3A), wherein when the mechanical coding (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) does not match (when the respective thread types, thread profiles, and/or thread pitches of the respective codings are substantially different from each other) the mechanical counter coding (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) the mechanical coding (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) and the mechanical counter coding (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) are operable to prevent a mutual assembly (one of ordinary skill in the art would conclude substantially different thread types, thread profiles, and/or thread pitches would prevent the first and second housing components from being mutually assembled since the respective thread types, thread profiles, and/or thread pitches would not be able to interact with each other as designed) of the first housing component (300) and the second housing component (10/350) in the final assembly configuration (Figure 9).
As to Claim 27, Sanofi teaches all the limitations of Claims 16 & 26, and continues to teach the mechanical coding (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) comprises a coding feature (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) integrated into the helical thread (327, modified to be a thread, as described in Paragraph 0075), and wherein the mechanical counter coding (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) comprises a counter coding feature (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) integrated into the helical counter thread (351, modified to be a thread, as described in Paragraph 0075).
As to Claim 28, Sanofi teaches all the limitations of Claims 16 & 26-27, and continues to teach the coding feature (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) is defined by at least one of a thread type, a thread profile and a thread pitch (the thread type, thread profile, or thread pitch of the helical thread 327, modified to be a thread, described in Paragraph 0075) of the helical thread (327, modified to be a thread, as described in Paragraph 0075) and wherein the counter coding feature (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) is defined by at least one of a thread type, a thread profile and a thread pitch (the thread type, thread profile, or thread pitch of the helical counter thread 351, modified to be a thread, described in Paragraph 0075) of the helical counter thread (351, modified to be a thread, as described in Paragraph 0075).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bitdinger (2003/0109834 – see Figure 5) and Plumptree (2014/0012208 – see Figures 2/3) describe similar housings.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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