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
This office action is responsive to the amendment filed on March 12, 2026. As directed by the amendment: claims 16-17 and 19 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) rejection of the previous action.
Response to Arguments
Applicant's arguments filed March 12, 2026 have been fully considered but they are not persuasive.
On page 7 of the Remarks, Applicant argues the newly amended preamble. In response, Examiner points to the rejection below.
On page 7 of the Remarks, Applicant argues that Way does not teach claim 16 lines 7-9 “…a male fitting…adapted to connect only to a complementary female fitting of the discriminating connector of the enteral feeding element..”. Applicant points out that the male port plug 14 of Way may be connected to enteral feeding tubes and related intravenous feeding systems, as taught by Way P0026. In response, Examiner notes that claim 16 is an apparatus claim and is interpreted such that that the male port plug 14 need only be fully capable of connecting to only a complementary female fitting of the discriminating connector of the enteral feeding element. Although Way teaches potential connection with intravenous feeding systems, it is fully capable of connecting only to enteral feeding tubes.
On page 7 of the Remarks, Applicant summarizes previous arguments, see above.
Claim Rejections - 35 USC § 112
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 16-21 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 16 lines 11-13 recite “…wherein the mating member of the male fitting is adapted to be inserted into a top opening of the central passage of the tapered connector and advanced into the mating member of the male fitting such that 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 to form a sealed passage extending from the male fitting through the tapered connector…”. This is unclear because its saying that the mating member is adapted to be advanced into the mating member (in other words, its adapted to advance itself). For purposes of examination, relevant portions of lines 10-13 are interpreted as “…wherein the mating member of the male fitting is adapted to be inserted into a top opening of the central passage of the tapered connector and advanced into [[Claims 17-21 are rejected at least because they depend from claim 16.
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 16-18 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Way US 2015/0032089 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 mating member of the male fitting such that 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).
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Regarding claim 17, Way discloses 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 (fluid tight seal, P0029), interference fit (friction fit, P0029).
Regarding claim 18, Way discloses the adapter assembly of claim 16, wherein the mating member (34, Fig. 2A) of the male fitting comprises a tapered portion (see Fig. 2A) and wherein a first section (first section, see annotated Fig. 3B below) of the central passage of the tapered connector comprises a constant diameter (see annotated Fig 3B below).
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Regarding claim 20, Way discloses the adapter assembly of claim 16, wherein a first section (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 (receptacle portion 46, P0029) extending from a top of the tapered connector (Fig. 1A).
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Regarding claim 21, Way discloses the adapter assembly of claim 16, wherein the tapered outer surface comprises a stepped configuration (stepped configuration, see annotated Fig. 1A above).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Way in view of Swisher US 2016/0361235 A1.
Regarding claim 19, Way discloses the adapter assembly of claim 16.
Way does not explicitly teach a complementary female fitting of the enteral feeding element (syringe, P0027) is incompatible with the top opening of the central passage of the tapered connector.
However, Swisher teaches an adapter assembly 10 P0016 and shown in Fig. 2 to allow a syringe to fluidly connect with a fluid conduit or reservoir, wherein the syringe has a complementary female fitting 17 P0016 designed to fluidly connect the syringe to the fluid conduit or reservoir via the adapter (adapter is a connector for joining parts or devices having different sizes, designs, etc., enabling them to be fitted or to work together, see dictionary.com definition attached, so that the syringe is incompatible with the fluid conduit or reservoir without the adapter).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the syringe of Way with a complementary female fitting as taught by Swisher for the purpose of fluidly connecting the syringe to the fluid conduit or reservoir via the male fitting, Swisher P0016.
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
THIS ACTION IS MADE FINAL. 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 JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783