DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/19/2026 has been entered.
Specification
The disclosure is objected to because of the following informalities:
Para 24 recites refers to reference character “1c” as both “groove or recess 1c” and “retaining elements 1c [that] are released from their retaining position”. Based on the drawings, the “groove or recess 1c” is not “released”, but rather lugs 2b are “released” from the groove or recess 1c. So the recitation of “retaining elements 1c are released from their retaining position” should actually recite “lugs 2b are released from groove or recess 1c”.
Para 31 recites that, when the resilient elements 3a are released, they are “able to deflect or move outwardly via cut-out 2e”. However, “cut-out 2e” should be “cut-out 2c” (based on Para 26) and Fig 4a shows the resilient elements 3a deflecting inwardly, not outwardly. So the recitation that the elements 3a are “able to deflect or move outwardly via cut-out 2e” should actually recite “able to deflect or move inwardly via cut-out [[2e]] 2c”.
Para 31 also recites that, due to the chamfer on the ribs 1a, resilient elements 3a “are deflected outwardly by the force of the injection spring 5 so that the dispensing operation is automatically triggered” and that the injection spring 5 “applies the force which is needed to deflect the resilient elements 3a outward and thus release the plunger rod”. However, Fig 4A shows that the resilient elements are deflected inwardly by the force of the injection spring to release the plunger rod and automatically trigger the dispensing operation. So the recitation that the resilient elements 3a are deflected “outwardly” should actually recite that the resilient elements are deflected “inwardly” and the recitation that the force applied by the injection spring 5 deflects the resilient elements 3a “outward” should actually recite that the force applied by the injection spring 5 deflects the resilient elements 3a “inward”.
Appropriate correction is required.
Claim Objections
Claims 5-8 and 11 are objected to because of the following informalities: In order to be grammatically correct, a comma should be placed after the term “wherein” in each of claims 5, 6, 7, 8 and 11. 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 1-11 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.
Claim 1 has been amended to recite that “a radially inward movement between the retaining element and the displaceable lock from the first position towards the longitudinal axis to a second position, releases the at least one retaining element to thereby release the plunger rod”. However, based on Para 31 of the disclosure, it is not the radially inward movement between the retaining element 3a and the displaceable lock 2 that “releases the at least one retaining element to thereby release the plunger rod”. Rather, the radially inward movement is how the retaining element 3a moves when it is being released. Instead, Para 31 recites that it is longitudinal movement of the displaceable lock 2 that releases the retaining elements 3a to thereby release the plunger rod 3 (Para 31 – “the protective sleeve 2 is moved rearwardly toward or into the rear position until the resilient elements 3a of the plunger rod 3 are released and able to deflect or move outwardly via a cut-out 2e in the protective sleeve 2”1). Therefore, the newly-added subject matter of claim 1 constitutes new matter since it is not supported by the original disclosure.
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 1-11 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.
Claim 1 has been amended to recite that “a radially inward movement between the retaining element and the displaceable lock from the first position towards the longitudinal axis to a second position, releases the at least one retaining element to thereby release the plunger rod” but this is not the same action as presented in the original disclosure. Based on Para 31 and Fig 4a of the disclosure, it is longitudinal movement of the displaceable lock 2 that releases the retaining elements 3a to thereby release the plunger rod 3 (Para 31 – “the protective sleeve 2 is moved rearwardly toward or into the rear position until the resilient elements 3a of the plunger rod 3 are released and able to deflect or move outwardly via a cut-out 2e in the protective sleeve 2”2), not radially inward movement between the retaining element 3a and the displaceable lock 2 that “releases the at least one retaining element to thereby release the plunger rod”. Rather, the radially inward movement is how the retaining element 3a moves when it is being released. Because the actions of the claim differ from the actions described in the specification, it is unclear how to interpret claim 1 in light of the specification.
For the sake of examination, claim 1 is interpreted as reciting “wherein the displaceable lock moves relative to the retaining element from the first position which causes the retaining element to move radially inward
Claim 1 requires “a displaceable lock” that holds the retaining element in a retaining position and that moves relative to the retaining element to release the retaining element and claim 4 requires “a protective sleeve” that is configured to be urged by a spring in the distal direction, configured to be pushed against an injection surface, and causes the needle to be manually inserted into the injection surface as the sleeve moves in a proximal direction into an insertion position; claim 5 further requires that the displaceable lock can be moved to the second position when the protective sleeve is in its insertion position and claim 7 further requires the protective sleeve to be pushed distally by the spring to a locked state. Although claimed as two distinct structure, the specification and drawings appear to set forth that the “protective sleeve” and the “displaceable lock” are a single structure – “protective sleeve 2”. See Para 5 (“displaceable locking sleeve”), para 6 (“a displaceable locking unit, e.g. a cover sleeve”), para 7 (“a moving or sliding locking element is also provided on or in the injection device, for example a sleeve, e.g. a protective sleeve”, para 8 (“the locking element or sleeve is a protective sleeve”, para 34 (“the protective sleeve 2 acting as a locking web”). Because the claims require two structures to perform the claimed actions but the specification only discloses one structure – “protective sleeve 2” – that performs all of the claimed actions, it is unclear how to interpret claims 4-9 in light of the specification.
For the sake of examination, the “displaceable lock” and the “protective sleeve” are interpreted as being the same structure since this is what is supported by the original disclosure. Specifically, claim 4 is interpreted as reciting “wherein the displaceable lock is formed as a protective sleeve and the injection device further comprises a spring”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 10 and 11 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lavi et al. (PG PUB 2005/0027255).
Re claim 1, Lavi discloses an injection device 30 (Fig 2,4,26-36; it is noted that all reference characters cited below refer to these figures unless otherwise noted) for administering a substance (Para 81), comprising: a housing 160 with an exterior (facing radially outward in Fig 2,4) configured to be held by a user (Para 81), the housing defining a longitudinal axis of the injection device (extending vertically in Fig 4); a syringe 500 with a needle 512 (seen in Fig 4, labeled in Fig 37) and a stopper 520 (seen in Fig 4, labeled in Fig 37), the syringe connected to the housing in an axially fixed manner (Para 115) during manual piercing by the needle by pushing the injection device onto or against a surface (Para 81); a plunger rod 350 which is movable in the housing (Para 116), the plunger rod formed as a unitary component (as seen in Fig 26) with a proximal end (directed upward in Fig 4) and a distal end (directed downward in Fig 4), the proximal end forming or fixedly attached to at least one retaining element 363 (as seen in Fig 26, the proximal end of the plunger rod is “fixedly attached” to the retailing element 363 via arm 361) which holds the plunger rod relative to the housing (Para 114), the distal end configured to be received within the syringe (as seen in Fig 4) and push against and move the stopper for dispensing the substance through the needle (Para 81); an injection spring 450 (Para 94) which is supported at a distal end (directed downward in Fig 4) against the plunger rod (as seen in Fig 32) and at a proximal end (directed upward in Fig 4) against the housing or an element connected to the housing (as seen in Fig 4); and a displaceable lock 250 displaceable within the housing (Para 87), wherein in a first position (seen in Fig 32,33), the displaceable lock holds the at least one retaining element in a positive locking relationship in a retaining position relative to the housing against a force of the injection spring in a tensed state (Para 121), and wherein the displaceable lock moves relative to the retaining element from the first position to a second position (seen in Fig 34,35) which causes the retaining element to move radially inward to thereby release the plunger rod (Para 121)3.
Re claim 2, Lavi discloses that the displaceable lock comprises a retaining region 274 which holds the at least one retaining element in the first position (Para 120).
Re claim 3, Lavi discloses that the syringe is fixedly mounted in the housing (Para 115).
Re claim 10, Lavi discloses that, upon the displaceable lock releasing the at least one retaining element, a dispensing operation is automatically triggered (Para 121).
Re claim 11, Lavi discloses that prior to the displaceable lock reaching the second position, the dispensing operation is prevented (Para 120,121).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2 and 4-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hommann et al. (PG PUB 2005/0203466) in view of Lavi et al. (PG PUB 2005/0027255).
Re claim 1, Hommann discloses an injection device (as seen in Fig 1-7; it is noted that all reference characters cited below refer to Fig 1-7 unless otherwise noted) for administering a substance (Para 2), comprising: a housing 1+2 with an exterior (facing radially outward in Fig 1-7) configured to be held by a user (Para 32), the housing defining a longitudinal axis (extending vertically in Fig 2) of the injection device; a syringe 7 with a needle 10 and a stopper 8, the syringe connected to the housing in an axially fixed manner (the cannot move off the longitudinal axis and therefore is “axially fixed”) during manual piercing by the needle by pushing the injection device onto or against a surface (Para 32 states that a user has to push the injection device against a surface in order to trigger it to insert the needle into the skin; therefore, this is considered “manual piercing”); a plunger rod 12 which is movable in the housing (as seen in Fig 4-7), the plunger rod formed as a unitary component with a proximal end (directed upward in Fig 2) and a distal end (directed downward in Fig 2), the proximal end forming or fixedly attached to at least one retaining element 13 which holds the plunger rod relative to the housing (prior to being acted upon by triggering ring 28, Para 32), the distal end configured to push against and move the stopper for dispensing the substance through the needle (Para 26); an injection spring 14 which is supported at a distal end (directed downward in Fig 2) against the plunger rod (as seen in Fig 2) and at a proximal end (directed upward in Fig 2) against the housing or an element connected to the housing (as seen in Fig 2); and a displaceable lock 4 or 11 (for claim 2, the “displaceable lock” is element 11 but for all other claims, the displaceable lock is element 4) displaceable within the housing (as seen in Fig 3-4; Para 32), wherein in a first position (seen in Fig 3), the displaceable lock holds the at least one retaining element in a positive locking relationship in a retaining position relative to the housing against a force of the injection spring in a tensed state (until acted upon by triggering ring 28, Para 32), and wherein the displaceable lock moves relative to the retaining element from the first position to a second position (seen in Fig 4) which causes the retaining element to move radially inward to thereby release the plunger rod (Para 32)4. Hommann does not disclose that the distal end of the plunger rod is configured to be received within the syringe, but rather pushes against a piston rod 9 of the syringe in order to push against the stopper.
Lavi, however, teaches a substantially similar injection device (seen in Fig 2,4,26-36) comprising a housing 160 (Fig 4), a syringe 500 (Fig 4) with a stopper 520 (seen in Fig 4, labeled in Fig 37), a plunger rod 350 (Fig 4) that is movable in the housing and has a retaining element 363 (Fig 26) which holds the plunger rod relative to the housing (Para 114), an injection spring 450 (Fig 4) which is supported at a distal end against the plunger rod (as seen in Fig 32) and at a proximal end against the housing or an element connected to the housing (Fig 4), and a displacement lock 250 (Fig 4) displaceable within the housing (Para 120), wherein the plunger rod is a unitary component (as seen in Fig 26) that has a distal end configured to be received within the syringe (as seen in Fig 4) and push against and move the stopper for dispensing the substance through a needle of the syringe (Para 81). Lavi teaches that the plunger rod acts directly on the stopper of the syringe so as to require a low production cost (Para 11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hommann to remove the piston rod 9 of the syringe and, instead, modify the plunger rod to be of a length that it acts directly on the stopper, as taught by Lavi, for the purpose of requiring a lower production cost (since the production of one item is less expensive than the production of two items) (Para 11).
Re claim 2, Hommann discloses that the displaceable lock 11 comprises a retaining region (at the proximal end thereof) which holds the at least one retaining element in the first position (as seen in Fig 3, Para 32).
Re claim 4, Hommann discloses that the displaceable lock 4 is formed as a protective sleeve (Para 25) and the injection device further comprises a spring 22 configured to urge the protective sleeve in a distal direction (Para 30), wherein when the protective sleeve is pushed against an injection surface, the protective sleeve moves in a proximal direction and into the housing (Para 31) and the needle is caused to be manually inserted into the injection surface in an insertion position of the protective sleeve (Para 32) 5.
Re claim 5, Hommann discloses that, when the protective sleeve is in the insertion position, the displaceable lock can be moved to the second position (Para 32).
Re claim 6, Hommann discloses that, upon the displaceable lock releasing the at least one retaining element, a dispensing operation is automatically triggered (Para 32).
Re claim 7, Hommann discloses that, upon removal of the injection device from the injection surface, the spring pushes the protective sleeve in the distal direction into a front-most position to a locked state (seen in Fig 7) where the protective sleeve is blocked from moving (Para 34).
Re claim 8, Hommann discloses that ,upon removal of the injection device from the injection surface, the spring pushes the protective sleeve in the distal direction into a front-most position to a locked state (seen in Fig 7) where the protective sleeve is blocked from moving (Para 34).
Re claim 9, Hommann discloses that the protective sleeve is mounted in the housing so that the protective sleeve is prevented from rotating (since locking tongue 25 must abut inner heel 27 of the protective sleeve 4, Para 26).
Re claim 10, Hommann discloses that, upon the displaceable lock releasing the at least one retaining element, a dispensing operation is automatically triggered (Para 32).
Re claim 11, Hommann discloses that, prior to the displaceable lock reaching the second position, the dispensing operation is prevented (Para 32).
Response to Arguments
Applicant’s arguments filed 5/12/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Although the Lavi reference utilized above was used in the last Office Action as a secondary reference, no arguments were directed to this reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 See the Specification objection set forth in item 3.b above for an explanation of what this passage in Para 31 should actually state.
2 See the Specification objection set forth in item 3.b above for an explanation of what this passage in Para 31 should actually state.
3 See the 112, second paragraph rejection above for an explanation of this interpretation.
4 See the 112, second paragraph rejection above for an explanation of this interpretation.
5 See the 112, second paragraph rejection above for an explanation of this interpretation.
Prosecution Insights