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 .
This action is in response to Applicant’s election filed on October 22nd, 2025.
Claims 1-15 are being examined in this office action.
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1-15, in the reply filed on October 22nd, 2025 is acknowledged. The traversal is on the ground(s) that no serious burden exists to search and examine each of Inventions I-III together. This is not found persuasive because there is a serious search burden that exists which was established in the requirement for restriction/election. For further example, Invention I would have a different search and/or examination burden from Invention II, since Invention II has a drive assembly comprising a rotational spring, which Invention I does not disclose. For further example, Invention I would have a different search and/or examination burden from Invention III, since Invention III has a drive arm, which Invention I does not disclose.
There is a similar search and/or examination burden that relates to the other Inventions mentioned in the requirement for restriction/election since these inventions are unrelated, showing that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects.
Further, even though all claim groups include common elements, the subject matter of the inventions are different. Therefore, for the reasons given above and in the requirement of restriction/election, there would be a serious search and/or examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 22nd, 2025.
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.
Claims 1, 3-5, 10-11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Loeb et al. (US Patent No. 4525164 A, herein, Loeb).
Regarding claim 1, Loeb discloses a reservoir and drive assembly for a medical injector (Fig.1) comprising:
a curved barrel (16 – Fig.1) having a first end and a second end positioned opposite the first end, the curved barrel defining an interior space configured to receive a fluid (“displace a liquid medication within the barrel” – Col.4, lines 13-14);
a stopper (18 – Fig.1) received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel (“move the piston along the barrel displacing the medication out of the barrel” – Col.5, lines 20-22);
a curved plunger rod (19 – Fig.1) having a first end and a second end positioned opposite from the first end, the curved plunger rod connected to the stopper (“piston which is slidably contacted by a cupped distal end of the stem” – Col.4, lines 25-26); and
at least one actuator (24 – Fig.1) inducing movement of the stopper within the curved barrel (Col.4, lines 9-14).
Regarding claim 3, Loeb discloses the reservoir and drive assembly as recited above, wherein the curved barrel (16 – Fig.1) is curved along an entire length extending from the first end of the curved barrel to the second end of the curved barrel (Fig.1).
Regarding claim 4, Loeb discloses the reservoir and drive assembly as recited above, wherein the curved plunger rod (19 – Fig.1) is curved along an entire length extending from the first end of the curved plunger rod to the second end of the curved plunger rod (Fig.1).
Regarding claim 5, Loeb discloses the reservoir and drive assembly as recited above, further comprising an electric motor (42 – Fig.1) configured to drive the at least one actuator (Col.4, lines 44-48).
Regarding claim 10, Loeb discloses the reservoir and drive assembly as recited above, wherein the curved barrel has a circular cross-section along a direction extending perpendicular to a curved central axis extending from the first end to the second end of the curved barrel (Fig.3).
Regarding claim 11, Loeb discloses a medical injector (Fig.1) comprising:
a curved barrel (16 – Fig.1) having a first end and a second end positioned opposite the first end, the curved barrel defining an interior space configured to receive a fluid (“displace a liquid medication within the barrel” – Col.4, lines 13-14);
a stopper (18 – Fig.1) received within the interior space, the stopper configured to move within the curved barrel to dispense fluid from the curved barrel (“move the piston along the barrel displacing the medication out of the barrel” – Col.5, lines 20-22);
a curved plunger rod (19 – Fig.1) having a first end and a second end positioned opposite from the first end, the curved plunger rod connected to the stopper (“piston which is slidably contacted by a cupped distal end of the stem” – Col.4, lines 25-26);
at least one actuator (24 – Fig.1) inducing movement of the stopper within the curved barrel (Col.4, lines 9-14);
a power source (43 – Fig.1, Col.4, lines 52-53); and
a cannula (34 – Fig.1) configured to be inserted into a skin of a patient.
Regarding claim 13, Loeb discloses the medical injector as recited above, wherein the curved barrel (16 – Fig.1) is curved along an entire length extending from the first end of the curved barrel to the second end of the curved barrel (Fig.1).
Regarding claim 14, Loeb discloses the medical injector as recited above, wherein the curved plunger rod (19 – Fig.1) is curved along an entire length extending from the first end of the curved plunger rod to the second end of the curved plunger rod (Fig.1).
Regarding claim 15, Loeb discloses the medical injector as recited above, further comprising an electric motor (42 – Fig.1) configured to drive the at least one actuator (Col.4, lines 44-48).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 12 under 35 U.S.C. 103 as being unpatentable over Loeb.
Regarding claim 2, Loeb discloses the reservoir and drive assembly as recited above, wherein the curved plunger rod and at least a portion of the stopper are in contact to dispense medication out of the barrel (Col.5, lines 21-22) but Loeb fails to explicitly disclose wherein the curved plunger rod and at least a portion of the stopper are formed integrally.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the curved plunger rod and at least a portion of the stopper to be formed integrally since it has been held that the use of one-piece construction would be merely a matter of obvious engineering choice, MPEP 2144.04 V B. In the instant case, the device of Loeb would still dispense medication out the barrel with the curved plunger rod and at least a portion of the stopper being formed integrally considering Loeb discloses a curved plunger rod and at least a portion of the stopper in cooperative engagement to dispense medication out of the barrel. Further, applicant places no criticality on the curved plunger rod and at least a portion of the stopper to be formed integrally, indicating simply “The curved plunger rod and the stopper may be formed integrally or may be formed separately” – Para [0028].
Regarding claim 12, Loeb discloses the medical injector as recited above, wherein the curved plunger rod and at least a portion of the stopper are in contact to dispense medication out of the barrel (Col.5, lines 21-22) but Loeb fails to explicitly disclose wherein the curved plunger rod and at least a portion of the stopper are formed integrally.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the curved plunger rod and at least a portion of the stopper to be formed integrally since it has been held that the use of one-piece construction would be merely a matter of obvious engineering choice, MPEP 2144.04 V B. In the instant case, the device of Loeb would still dispense medication out the barrel with the curved plunger rod and at least a portion of the stopper being formed integrally considering Loeb discloses a curved plunger rod and at least a portion of the stopper in cooperative engagement to dispense medication out of the barrel. Further, applicant places no criticality on the curved plunger rod and at least a portion of the stopper to be formed integrally, indicating simply “The curved plunger rod and the stopper may be formed integrally or may be formed separately” – Para [0028].
Claims 6-7 under 35 U.S.C. 103 as being unpatentable over Loeb in view of Langley et al. (US Pub No. 20040087904 A1, herein, Langley).
Regarding claim 6, Loeb discloses the reservoir and drive assembly as recited above wherein, the at least one actuator (24 – Fig.1) comprises a pinion gear (24 – Fig.1).
Langley teaches a reservoir and drive assembly comprising a worm gear (48 – Fig.2) and a planetary gear set (24 – Fig.2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir and drive assembly of Loeb to comprise a worm gear and a planetary gear set as taught by Langley in addition to the existing pinion gear of Loeb since the worm gear and planetary gear would drive the pinion gear, providing controlled torque transmission and mechanical reduction of the assembly.
Regarding claim 7, Loeb discloses the reservoir and drive assembly as recited above, comprising an electric motor (42 – Fig.1), but Loeb does not explicitly disclose wherein the electric motor comprises a drive shaft, the worm gear secured to the drive shaft, the pinion gear engaged with the worm gear and the planetary gear set.
Langley teaches a reservoir and drive assembly wherein a dial dose (42 – Fig.1) comprises a drive shaft (40 – Fig.1), a worm gear (48 – Fig.2) secured to the drive shaft (Fig.2), the outer gear (22 – Fig.2) engaged with the worm gear and the planetary gear set (Para [0025]-[0026]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electric motor of Loeb to comprise a drive shaft, the worm gear secured to the drive shaft, the outer gear engaged with the worm gear and the planetary gear set as taught by Langley since the drive shaft drives the worm gear that is attached to the drive shaft causing the outer gear and the planetary gear set to rotate causing controlled torque transmission (Langley, Para [0028], [0036]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Loeb in view of Olivas et al. (US Pub No. 20210154410 A1).
Regarding claim 9, Loeb discloses the reservoir and drive assembly as recited above but Loebdoes not disclose the assembly further comprising a printed circuit board assembly wherein the printed circuit board assembly is C-shaped.
Olivas teaches a reservoir and drive assembly comprising a printed circuit board assembly (88 – Fig.3) wherein the printed circuit board assembly is curved and rectangular. Olivas does not explicitly disclose the printed circuit board assembly being C-shaped.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir and drive assembly of Loeb to comprise a printed circuit board as taught by Olivas since a printed circuit board is widely used in medical devices, providing a compact and organized circuitry and it would also be obvious to modify the shape of the printed circuit board of Olivas to be C-shaped since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B. In the instant case, the device of Loeb would not operate differently with the claimed shape of the printed circuit board taught by Olivas considering Olivas teaches a printed circuit board being curved and rectangular in shape. Further, applicant places no criticality on the shape claimed, indicating simply “the medical injector includes a C-shaped printed circuit board assembly” – Para [0029].
Allowable Subject Matter
Claim 8 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Junod et al. (US 20160263312 A1) discloses a portable pump comprising a curved reservoir and a gear set.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm 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 at (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.
/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783