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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/2025 has been entered.
Claim Objections
Claims 8 and 17 are objected to because of the following informalities: Each of claims 8 and 17 are grammatically incorrect; in order to be grammatically correct, the comma on line 3 of each of these claims should be removed. Appropriate correction is required.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kramer et al. (US Pat 5,326,236).
Re claim 1, Kramer discloses a drug delivery device (Fig 9) for delivering a medicament (it is noted that the italicized text constitutes functional language and, therefore, “a medicament” is not a part of the claimed invention; this limitation is met in view of Col 1, Lines 15-17), comprising: a housing 121+122+173 (Fig 1,9); a fluid displacement assembly 152+154+155+156 (Fig 1) at least partially supported by and/or surrounded by the housing (as seen in Fig 13; Col 5, Lines 40-68), the fluid displacement assembly including a ring tube portion 154 (Fig 1); a drive component 173+145 (Fig 9) at least partially supported by and/or surrounded by the housing (as seen in Fig 13; Col 5, Lines 40-68 and Col 6, Lines 3-6), the drive component including an eccentric component 145 (Fig 1) having a non-circular contact surface (the radially-outer surface of one of beam members 146c, as seen in Fig 3) configured to directly or indirectly apply, from only one side of the eccentric component, a compression force to a compression patch (the portion of the ring tube portion 154 that is in direct contact with sleeve 152, as seen in Fig 1) of the ring tube portion such that when the eccentric component rotates about an axis, the non-circular contact surface moves along a generally circular path and drives the medicament through the fluid displacement assembly (Col 1, Lines 15-17 and Col 2, Lines 3-8); wherein the compression force between the non-circular contact surface and the ring tube portion is substantially constant throughout a complete revolution about the axis by the eccentric component (Col 2, Lines 25-30).
Re claim 2, Kramer discloses that the ring tube portion defines a generally circular shape (as seen in Fig 1; due to it being wrapped around sleeve 152, Col 5, Lines 41-42).
Re claim 3, Kramer discloses that the ring tube portion includes a first point that overlaps with a second point (as seen in Fig 1 in dashed line).
Re claim 4, Kramer discloses that the ring tube portion defines a fluid flow path having a generally spiral shape (as seen in Fig 1; due to it being wrapped around sleeve 152, Col 5, Lines 41-42).
Re claim 5, Kramer discloses that the compression force between the non-circular contact surface and the ring tube portion is substantially uninterrupted throughout a complete revolution about the axis by the eccentric component (Col 2, Lines 25-30).
Re claim 6, Kramer discloses that at least a portion 145 (Fig 1) of the fluid displacement assembly is at least partially disposed within a disposable housing portion 121+122 (Fig 2) of the housing (as seen in Fig 13; Col 5, Lines 40-68).
Re claim 7, Kramer discloses that at least a portion 173 (Fig 9) of the drive component is at least partially disposed within a durable housing portion 172 (Fig 9) of the housing (as seen in Fig 9).
Re claim 8, Kramer discloses that the fluid displacement assembly includes a sleeve bearing 152 (Fig 1) and a pump race 126+127a+127b (Fig 1), the ring tube portion adapted to be at least partially disposed within the pump race (as seen in Fig 13; Col 5, Lines 42-47), and to wrap around an outer periphery of the sleeve bearing (as seen in Fig 1; Col 5, Lines 41-42).
Re claim 9, Kramer discloses that the sleeve bearing is positioned between the eccentric component and the ring tube portion (as seen in Fig 1; Col 5, Lines 40-42).
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 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (US Pat 5,326,236) in view of Natwick (US Pat 5,357,827).
Re claim 10, Kramer discloses a drug delivery system (Fig 9) for delivering a drug product (it is noted that the italicized text constitutes functional language and, therefore, “a drug product” is not a part of the claimed invention; this limitation is met in view of Col 1, Lines 15-17), comprising: a fluid path (the tubing directly connected to inlet port 155, seen to the left of inlet port 155 in Fig 1 but not labeled) configured to receive drug product from a drug product container (Col 5, Lines 6-10); and a drug delivery device (all components seen in Fig 9 except for the tubing leading to inlet port 155 and the tubing leading from outlet port 156) positioned along and/or adjacent to the fluid path (as seen in Fig 9); wherein the drug delivery device includes: a housing 121+122+173 (Fig 1,9); a fluid displacement assembly 152+154+155+156 (Fig 1) at least partially supported by and/or surrounded by the housing (as seen in Fig 13; Col 5, Lines 40-68), the fluid displacement assembly including a ring tube portion 154 (Fig 1); a drive component 173+145 (Fig 9) at least partially supported by and/or surrounded by the housing (as seen in Fig 13; Col 5, Lines 40-68 and Col 6, Lines 3-6), the drive component including an eccentric component 145 (Fig 1) having a non-circular contact surface (the radially-outer surface of one of beam members 146c, as seen in Fig 3) configured to directly or indirectly apply, from only one side of the eccentric component, a compression force to a compression patch (the portion of the ring tube portion 154 that is in direct contact with sleeve 152, as seen in Fig 1) of the ring tube portion such that when the eccentric component rotates about an axis, the non-circular contact surface moves along a generally circular path and drives the drug product through the fluid displacement assembly (Col 1, Lines 15-17 and Col 2, Lines 3-8); wherein the compression force between the non-circular contact surface and the ring tube portion is substantially constant throughout a complete revolution about the axis by the eccentric component (Col 2, Lines 25-30). Even though Kramer discloses that the system is intended to deliver a drug product (Col 1, Lines 15-17), Kramer does not explicitly disclose that the system includes a drug product container containing the drug product.
Natwick, however, teaches a substantially similar drug delivery system (Fig 1) comprising a drug product container 32 (Fig 1) containing a drug product 31 (Fig 1; Col 1, Line 24-26), a fluid path (the portion of tubing 34 extending from container 32 to drug delivery device 30 in Fig 1) configured to receive the drug product from the drug product container, and a drug delivery device 30 (Fig 1) positioned along and/or adjacent to the fluid path (as seen in Fig 1) for delivering the drug product to a patient (Col 4, Lines 30-38). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kramer to include a drug product container containing the drug product, as taught by Natwick, for the purpose of delivering a drug product to a patient (Col 4, Lines 30-38).
Re claim 11, Kramer discloses that the ring tube portion defines a generally circular shape (as seen in Fig 1; due to it being wrapped around sleeve 152, Col 5, Lines 41-42).
Re claim 12, Kramer discloses that the ring tube portion includes a first point that overlaps with a second point (as seen in Fig 1 in dashed line).
Re claim 13, Kramer discloses that the ring tube portion defines a fluid flow path having a generally spiral shape (as seen in Fig 1; due to it being wrapped around sleeve 152, Col 5, Lines 41-42).
Re claim 14, Kramer discloses that the compression force between the non-circular contact surface and the ring tube portion is substantially uninterrupted throughout a complete revolution about the axis by the eccentric component (Col 2, Lines 25-30).
Re claim 15, Kramer discloses that at least a portion 145 (Fig 1) of the fluid displacement assembly is at least partially disposed within a disposable housing portion 121+122 (Fig 2) of the housing (as seen in Fig 13; Col 5, Lines 40-68).
Re claim 16, Kramer discloses that at least a portion 173 (Fig 9) of the drive component is at least partially disposed within a durable housing portion 172 (Fig 9) of the housing (as seen in Fig 9).
Re claim 17, Kramer discloses that the fluid displacement assembly includes a sleeve bearing 152 (Fig 1) and a pump race 126+127a+127b (Fig 1), the ring tube portion adapted to be at least partially disposed within the pump race (as seen in Fig 13; Col 5, Lines 42-47), and to wrap around an outer periphery of the sleeve bearing (as seen in Fig 1; Col 5, Lines 41-42).
Re claim 18, Kramer discloses that the sleeve bearing is positioned between the eccentric component and the ring tube portion (as seen in Fig 1; Col 5, Lines 40-42).
Response to Arguments
Applicant’s arguments filed 7/25/2025 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 6,024,545 to Morioka (eccentric component 5, Fig 2), US Pat 5,173,038 to Hopfensperer et al. (eccentric component 8, Fig 1), PG PUB 2017/0268496 to McIntyre (eccentric component 2, Fig 2) each disclose a drive component comprising an eccentric component having a non-circular contact surface that applies compression force to a compression patch of a tube from only one side of the eccentric component.
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.
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, Kevin Sirmons can be reached at (571)272-4965. 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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783