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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 24, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on July 2, 2026. As directed by the amendment: claims 2 and 16 have been amended, claim 1 has been cancelled, and no claims have been added. Thus, claims 2-21 are presently pending in this application. Applicant’s amendments are sufficient to overcome the antecedent basis §112(b) rejections of the previous action.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 2, 2026, with respect to the rejection of newly amended independent claim 16 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kunishige et al. (Kunishige) US 2016/0206516 A1.
On pages 6-7 of the Remarks, Applicant argues newly amended claim 16. In response, Examiner points to the rejection below.
On pages 7-8 of the Remarks, Applicant argues that Way discourages the proposed modification. To the best of Examiner’s understanding, Applicant is arguing against modification to the connection between elements 14 and 16 of Way. However, the proposed modification noted below is to the connection between element 14 of Way and a complementary female fitting of the discriminating connector of the enteral feeding element.
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.
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 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Way US 2015/0032089 A1 in view of Kunishige et al. (Kunishige) US 2016/0206516 A1.
Regarding claim 16, Way discloses an adapter assembly (medical connector assembly 10 comprised of plugs 14 and 16, P0025-0027) for connecting an enteral feeding element to a fluid conduit or reservoir, wherein the enteral feeding element comprises a discriminating connector and the fluid conduit or reservoir comprises an opening that is incompatible with the discriminating connector of the enteral feeding element (MPEP 2111.02(II) recites “…statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference…between the claimed invention and the prior art.”. Here, the claimed invention is the adapter assembly, and the preamble does not result in a structural difference between the claimed invention and the medical connector assembly of Way because Way teaches a medical connector assembly for an enteral feeding element comprising a discriminating connector that is not compatible with the same enteral feeding element comprising a discriminating connector on both ends of the medical connector assembly, Way Figs. 1A-4), comprising: a tapered connector (plug 16, P0026) including a central passage (channel 40, P0031) and a tapered outer surface (tapered outer surface, see annotated Fig. 1A below), wherein the tapered outer surface is adapted to engage the opening of the fluid conduit or reservoir (the tapered outer surface is fully capable of engaging the opening of a fluid conduit or reservoir); a male fitting (plug 14, P0027) including a central passage therethrough (central passage, see annotated Fig. 4 below), an enteral feeding element connection end (end 18, P0027) adapted to connect only to a complementary female fitting of the discriminating connector of the enteral feeding element (end 18 is fully capable of connecting only to a complementary female fitting of a discriminating connector of the enteral feeding element because P0027 teaches end 18 is adapted to mate with a fluid source such as a syringe, P0027, and because although end 18 may connect to non-enteral fittings as described in P0026 of Way, the claim is interpreted such that it need only be fully capable of being connected to only enteral fittings during use) and a mating member (circumferential surface 34, P0028 and shown in Fig. 2A) adapted to be removably inserted into the central passage of the tapered connector (Figs. 1A-B and P0031), wherein the mating member of the male fitting is adapted to be inserted into a top opening of the central passage (top opening at first end 44, P0029 and shown in Fig. 3B) of the tapered connector and advanced into the central passage of the tapered connector such that the central passage of the tapered connector cooperates with the central passage of the male fitting (channel 22, P0031 and shown in Fig. 2B) to form a sealed passage (fluid tight seal, P0029) extending from the male fitting through the tapered connector (Fig. 4); wherein the tapered connector is adapted to be inserted into the opening of the fluid conduit or reservoir until the tapered outer surface forms an interface with the opening of the fluid conduit or reservoir (the tapered connector is fully capable of being inserted into the opening of the fluid conduit or reservoir until the tapered outer surface forms an interface with the opening of the fluid conduit or reservoir); and, wherein the complementary female fitting of the enteral feeding element is adapted to be connected to the enteral feeding element connection end of the male fitting (a syringe is fully capable of being connected to the enteral feeding element connection end of the male fitting).
PNG
media_image1.png
876
600
media_image1.png
Greyscale
PNG
media_image2.png
842
702
media_image2.png
Greyscale
Way does not teach the annular portion having a threaded inner surface adapted to connect to a complementary female fitting.
However, Kunishige teaches a connector 1 shown in Figs. 1A-C having a threaded inner surface (female screw 16, P0030) adapted to connect to a complementary female fitting (first female connector 6, P0049).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the annular portion of Way with threads as taught by Kunishige for the purpose of connecting with a portion of a feeding set for use in enteral nutrition, Kunishige P0039, and shown in Figs. 4A-C.
Regarding claim 17, Way in view of Kunishige teaches the adapter assembly of claim 16, wherein the mating member of the male fitting is configured to be received in the central passage of the tapered connector to form a liquid-tight (Way, fluid tight seal, P0029), interference fit (Way, friction fit, P0029).
Regarding claim 18, Way in view of Kunishige teaches the adapter assembly of claim 16, wherein the mating member (Way, 34, Fig. 2A) of the male fitting comprises a tapered portion (Way, see Fig. 2A) and wherein a first section (Way, first section, see annotated Fig. 3B below) of the central passage of the tapered connector comprises a constant diameter (Way, see annotated Fig 3B below).
PNG
media_image3.png
869
587
media_image3.png
Greyscale
Regarding claim 19, Way in view of Kunishige teaches the adapter assembly of claim 16, wherein the complementary female fitting of the enteral feeding element (Kunishige, first female connector 6, P0049) is incompatible with the top opening of the central passage of the tapered connector (top to opening of the central passage of the tapered connector of Way is not threaded).
Regarding claim 20, Way in view of Kunishige teaches the adapter assembly of claim 16, wherein a first section (Way, first section, see annotated Fig. 1A below) of the central passage of the tapered connector is spaced radially inwardly from the tapered outer surface by an annular channel (Way, receptacle portion 46, P0029) extending from a top of the tapered connector (Way, Fig. 1A).
PNG
media_image4.png
853
590
media_image4.png
Greyscale
Regarding claim 21, Way in view of Kunishige teaches the adapter assembly of claim 16, wherein the tapered outer surface comprises a stepped configuration (Way, stepped configuration, see annotated Fig. 1A above).
Allowable Subject Matter
Claims 2-15 are allowed.
Reasons for Allowance
The following is an Examiner's statement of reasons for allowance: the claims in this application are allowed because the prior art of record fails to disclose either singularly or in combination the claimed method of connecting an enteral feeding element to a fluid conduit or reservoir.
The closest prior art is Kunishige et al. (Kunishige) US 2016/0206516 A1.
Regarding claim 2, Kunishige fails to teach among all the limitations or render obvious a method of connecting an enteral feeding element to a fluid conduit or reservoir as claimed, which includes inserting the tapered connector into the opening of the fluid conduit or reservoir until the tapered outer surface forms an interface with the opening of the fluid conduit or reservoir, in combination with the total structure and function of the method of connecting an enteral feeding element to a fluid conduit or reservoir as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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.
/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights