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
The Amendment filed 04/09/2026 has been entered. Claims 1-6 & 8-11 are pending in the application. Claim 7 is cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
The needle through hole
The interlayer
The micro sealing door
The electromagnetic push rod
No new matter should be entered.
The drawings are objected to because of the following.
Element 8 –the sealing stack-- is pointing to a different structure in Figure 1 than in Figure 2
Element 11 –the central airway-- is pointing to a different structure in Figure 1 than in Figure 2
Element 9 –the sealing pressure rod-- is pointing to a different structure in Figure 1 than in Figure 2
Elements 2, 3 & 4 are pointing to the same structure in Figure 1
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they fail to comply with the following §1.84 sections.
New corrected drawings in compliance with §1.84(m) are required in this application because the shading, in each of the figures, makes it difficult to determine the structure of the claimed invention.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 5, 12, 24, 25, 26, 27.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities.
The specification refers to Figures 5-7, but there are no Figures 5-7, since none of the 04/09/2026 figures were entered
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 1-6 & 8-11 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.
As to Claim 1, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a sealing stack (8) embedded into a middle of the syringe plunger (6), and a sealing pressure rod (9) provided on a first side of the sealing stack (8) facing towards the pneumatic assembly. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe how the stack is capable of sealing or the rod is capable of providing a sealing pressure.
Instant application Paragraph 0023 describes the stack as “a unidirectional opening and self-closing stacking group”; which opens when suction is provided in the central airway, and closes with the absence of suction. However, sufficient structure has not been provided which would allow one of ordinary skill in the art to understand how the stack is capable of performing these functions while providing a sealing effect.
Instant application Paragraph 0023 also describes the sealing pressure rod as being comprised of a pressure rod arm and an air-controlled pressure rod shaft, where the air-controlled pressure rod shaft is actuated via air flowing through the pressure rod airway applying negative or positive pressure to the air-controlled pressure rod shaft, but this fails to describe how the air-controlled pressure rod shaft is able to drive the pressure rod arm. The instant application does not provide any means –i.e., structure on the air-controlled pressure rod shaft—which would allow one of ordinary skill in the art to conclude how the air-controlled pressure rod shaft is controlled via air. As such, the disclosure does not provide sufficient structure which would allow one of ordinary skill in the art to understand how the sealing pressure rod is capable of performing these functions while providing a sealing pressure effect.
As to Claim 2, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a needle sealing door. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe how the door is capable of sealing/unsealing the needle.
Instant application Paragraph 0022 describes the needle sealing door as being comprised of a BLUETOOTH controlled electromagnetic sealing door, which is an electromagnetic push rod, and comprised of a micro sealing door. The electromagnetic push rod can drive the door to open the needle tube through hole, and power is supplied by an induction coil. However, instant application Figure 1 shows the needle tube 2, the induction coil 4, and the needle sealing door 3 as the same structure. As such, one of ordinary skill in the art would not be able to determine how the door is capable of providing a sealing effect, since the door, needle tube and coil are all arranged as the same structure. As such, the disclosure does not provide sufficient written description for the needle sealing door.
As to Claim 4, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims an air-controlled pressure rod shaft (23). This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe how the rod is capable of being controlled via air.
Instant application Paragraph 0023 describes the sealing pressure rod as being comprised of a pressure rod arm and an air-controlled pressure rod shaft, where the air-controlled pressure rod shaft is actuated via air flowing through the pressure rod airway applying negative or positive pressure to the air-controlled pressure rod shaft, but this fails to describe how the air-controlled pressure rod shaft is able to drive the pressure rod arm. The instant application does not provide any means –i.e., structure on the air-controlled pressure rod shaft—which would allow one of ordinary skill in the art to conclude how the air-controlled pressure rod shaft is controlled via air. As such, the disclosure does not provide sufficient structure which would allow one of ordinary skill in the art to understand how the sealing pressure rod is capable of performing these functions while providing a sealing pressure effect.
As to Claim 11, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a needle sealing door (3), disposed between the syringe needle (1) and the needle tube (2) and configured to block the needle through hole (5); an induction coil (4), disposed between the syringe needle (1) and the needle tube (2), and electrically connected to the needle sealing door (3). This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe how the door is capable of sealing/unsealing the needle.
Instant application Paragraph 0022 describes the needle sealing door as being comprised of a BLUETOOTH controlled electromagnetic sealing door, which is an electromagnetic push rod, and comprised of a micro sealing door. The electromagnetic push rod can drive the door to open the needle tube through hole, and power is supplied by an induction coil. However, instant application Figure 1 shows the needle tube 2, the induction coil 4, and the needle sealing door 3 as the same structure. As such, one of ordinary skill in the art would not be able to determine how the door is capable of providing a sealing effect, since the door, needle tube and coil are all arranged as the same structure. As such, the disclosure does not provide sufficient written description for the needle sealing door.
Applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a sealing stack (8), embedded into a middle of the syringe plunger (6); a sealing pressure rod (9), disposed on a side of the sealing stack (8) facing away from the syringe needle (1)… a central airway (11), connected to the sealing stack (8), and configured to control opening or closing of the sealing stack (8); a pressure rod airway (15), connected to the sealing pressure rod (9); wherein the pressure rod airway (15) is configured to drive the sealing pressure rod (9) to lock the sealing stack (8), and the sealing stack (8) is not opened in a locking state. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe how the stack is capable of sealing or the rod is capable of providing a sealing pressure.
Instant application Paragraph 0023 describes the stack as “a unidirectional opening and self-closing stacking group”; which opens when suction is provided in the central airway, and closes with the absence of suction. However, sufficient structure has not been provided which would allow one of ordinary skill in the art to understand how the stack is capable of performing these functions while providing a sealing effect.
Instant application Paragraph 0023 describes the sealing pressure rod as being comprised of a pressure rod arm and an air-controlled pressure rod shaft, where the air-controlled pressure rod shaft is actuated via air flowing through the pressure rod airway applying negative or positive pressure to the air-controlled pressure rod shaft, but this fails to describe how the air-controlled pressure rod shaft is able to drive the pressure rod arm. The instant application does not provide any means –i.e., structure on the air-controlled pressure rod shaft—which would allow one of ordinary skill in the art to conclude how the air-controlled pressure rod shaft is controlled via air. As such, the disclosure does not provide sufficient structure which would allow one of ordinary skill in the art to understand how the sealing pressure rod is capable of performing these functions while providing a sealing pressure effect.
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 1-6 & 8-11 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.
As to Claim 1, the limitation “a sealing stack (8) embedded into a middle of the syringe plunger (6), and a sealing pressure rod (9) provided on a first side of the sealing stack (8) facing towards the pneumatic assembly”, in Lines 11-13, is indefinite. It is not clear how the stack is capable of sealing or the rod is capable of providing a sealing pressure. As described in the 112(a) rejection above, the disclosure does not provide sufficient description on how the stack is capable of performing these functions while providing a sealing effect. As such, it is not clear how the stack is capable of providing a sealing effect.
As to Claim 2, the limitation “a needle sealing door”, is indefinite. It is not clear how the door is capable of providing a sealing effect. As described in the 112(a) rejection above, the disclosure does not provide sufficient description on how the door provides a sealing effect. As such, it is not clear how the door provides a sealing effect, rendering the limitation indefinite.
As to Claim 4, the limitation “an air-controlled pressure rod shaft (23)”, is indefinite. It is not clear how the pressure rod shaft is controlled via air. As described in the 112(a) rejection above, the disclosure does not provide sufficient description on how the rod shaft is controlled via air. As such, it is not clear how the air-controlled pressure rod shaft is actuated via air, rendering the limitation indefinite.
As to Claim 11, the limitation “a needle sealing door (3), disposed between the syringe needle (1) and the needle tube (2) and configured to block the needle through hole (5); an induction coil (4), disposed between the syringe needle (1) and the needle tube (2), and electrically connected to the needle sealing door (3)”, is indefinite. It is not clear how the door is capable of providing a sealing effect. As described in the 112(a) rejection above, the disclosure does not provide sufficient description on how the door provides a sealing effect. As such, it is not clear how the door provides a sealing effect, rendering the limitation indefinite.
The limitation “a sealing stack (8), embedded into a middle of the syringe plunger (6); a sealing pressure rod (9), disposed on a first side of the sealing stack (8) facing away from the syringe needle (1)… a central airway (11), connected to the sealing stack (8), and configured to control opening or closing of the sealing stack (8); a pressure rod airway (15), connected to the sealing pressure rod (9); wherein the pressure rod airway (15) is configured to drive the sealing pressure rod (9) to lock the sealing stack (8), and the sealing stack (8) is not opened in a locking state” is indefinite. It is not clear how the stack is capable of sealing or the rod is capable of providing a sealing pressure. As described in the 112(a) rejection above, the disclosure does not provide sufficient description on how the stack is capable of performing these functions while providing a sealing effect. As such, it is not clear how the stack is capable of providing a sealing effect.
Response to Arguments
Applicant's arguments filed 04/09/2026 have been fully considered but they are not persuasive.
Regarding the Drawing Objections, the 04/09/2026 drawings were not entered. The drawings contained new matter, such as relative size dimensions in Figure 1, specifically the size of interlayer 25, sealing door 3, power converter 7, and sealing pressure rod 9. Figure 2 has similar problems. Figures 5/6 show previously undisclosed structural relationships between the microsealing door 24 and the remaining structure, as well as the movement of the microsealing door. Additionally, the dimensions of needle tube 2 are significantly different than original Figure 1. Figure 7 shows previously undisclosed movement and structural relationship of sealing stack 8. None of the figures have correct shading, making it difficult to determine the overall structure, and how each component is related to other components.
Regarding the 112(a) rejection for Claim 1, Applicant argues instant application Paragraph 0023 sufficiently describes how the sealing stack and sealing pressure rod are able to provide sealing and sealing pressure, respectively. Examiner disagrees.
Paragraph 0023 only broadly states the a negative pressure in the pressure rod airway results in the pressure rod shaft driving the pressure rod arm to open, allowing the sealing stack to open. However, this does not provide sufficient detail on how the pressure rod shaft is capable of using the negative pressure to actuate, in turn providing the necessary claimed sealing pressure. This is required for one of ordinary skill in the art to determine how the claimed invention functions, as claimed.
Note, the nomenclature used to describe each of the claimed structures is not normal nomenclature. Applicant should ensure the application was interpreted correctly. A poor interpretation may be contributing to a lack of understanding of the written description.
Regarding the 112(a) rejection for Claim 2, Applicant argues the drawing amendments clarify how the needle sealing door functions. As described above, the submitted drawings contained new matter, and were not drawn correctly. Applicant must submit new drawings without new matter and drawn properly before Examiner can consider Applicant’s arguments.
Regarding the 112(a) rejection for Claim 4, Applicant states the arguments for Claim 4 are similar to Claim 1.
For the same reasons, Examiner also disagrees with Applicant’s Claim 4 arguments.
Regarding the 112(a) rejection for Claim 11, Applicant states the arguments for Claim 11 are similar to Claims 1 & 2.
For the same reasons, Examiner also disagrees with Applicant’s Claim 11 arguments.
Regarding the remaining 112(b) rejections for each of the claims, Applicant argues each of the rejections have been overcome based on the arguments in their 112(a) arguments.
Similarly, Examiner disagrees for the same reasons as outlined in response to each of Applicant’s arguments above.
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 DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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 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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