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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/03/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/03/2026. As directed by the amendment: claims 14, 17, and 32-33 have been amended, no claims have been cancelled, and claims 34-35 have been added. Thus, claims 1-11, 14-15, 17, and 30-35 are presently pending in this application, with claims 1-11 being withdrawn from consideration. The 112(f) interpretation is maintained.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument on p.7-8 of “Remarks” filed 04/03/2026 that Davis fails to disclose or teach wherein the transmission portion connects the proximal cavity and the distal cavity and wherein a diameter of the transmission portion is less than a diameter of the proximal cavity and a diameter of the distal cavity as required by claims 14 and 17, the examiner respectfully disagrees. The applicant argues “the first end 240 [of Davis] comprises two distinct, concentrically arranged cavities”. This argument is not persuasive because the annotated proximal cavity of Davis shown below in Davis Drawing 1 is still a cavity located in the proximal end of the cap. There is no claim limitation restricting the cavity from containing additional structures such as the male tip 242 in Fig. 5D. Further, the transmission portion as annotated below does connect the distal cavity to at least a portion of the annotated proximal cavity as required by the claim, and thus the diameter of the transmission portion as annotated below is less than a diameter of the proximal cavity as annotated below.
Regarding the newly added claims 34-35, the examiner does not find the arguments on p.10 of “Remarks” filed on 04/03/2026 persuasive because the channel as annotated in Davis Drawing 2 below is configured to flow fluid through the cap from the inlet opening to the outlet opening. The claim does not require that the fluid has to flow through the entire inlet opening, and thus Davis discloses that the fluid flows through at least a portion of said inlet opening corresponding to the male tip 242.
Thus the rejection is maintained.
Examiner suggests amending claims 14 and 17 to disclose that the transmission portion connects an entirety of the proximal cavity and the distal cavity.
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Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a first connection element” in claim 17
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the first connection element in claim 17, the specification is referenced for the corresponding structures. Paragraph 0037 discloses the connection features as threads, clips, snaps, plugs, fittings, and/or other connector structures known for connecting a cap to an external receiving member. Furthermore, paragraph 0063 further discloses the connection features as a snap, a hook, and/or a friction coupling. Examiner will be interpreting these connecting structures as such.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 14, 17, and 30-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Davis et al. (U.S Patent Pub. No. 20170014616 A1, “Davis”),
Regarding claim 14, Davis discloses (Claim 14) a cap (230 in Fig. 5A-5F) comprising:
a cylindrical section (body of 230) comprising a proximal end (240 in Fig. 5D) and a distal end (250 in Fig. 5D);
a proximal cavity comprising an inlet opening positioned within the proximal end (240 in Fig. 5D) of the cylindrical section (body of 230, see annotated Davis drawing 1 below for proximal cavity and inlet opening – the proximal cavity is being interpreted as the entire cavity form by the collar 244 of the proximal end 240 with the inlet opening being the proximal opening of said entire cavity);
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a distal cavity comprising an outlet opening positioned within the distal end (250 in Fig. 5D) of the cylindrical section (body of 230, see annotated Davis drawing 1 above for distal cavity and outlet opening);
a transmission portion positioned between the proximal cavity and the distal cavity (see annotated Davis drawing 1 above – the transmission portion is being interpreted as the portion having diameter D11), wherein the transmission portion connects the proximal cavity and distal cavity (see annotated Davis 1 drawing above);
a first threaded connection (internal threads of 244) positioned around an inner circumference of a walled section (244 in Fig. 5D) defining the proximal cavity (see annotated Davis drawing 1 above for proximal cavity, Fig. 5D and para. 0059); and
a second threaded connection (252 in Fig. 5A) positioned around an outer circumference of the distal end (250) of the cylindrical section (body of 230, see Fig. 5A and para. 0060 – the pair of partial thread lugs 252 are being interpreted as the second threaded connection as they form a threaded engagement), wherein the distal end (250) with the second threaded connection (252 in Fig. 5A) is configured for direct connection to an enteral line (see para. 0060 – the pair of partial thread lugs 252 engage directly with a male ENFIT tip of a syringe as seen in Fig. 2 indicating direct connection to an enteral line), wherein the second threaded connection (252 in Fig. 5A) is a connector according to ISO 80369-3 (see para. 0060 – the distal end 250 having the pair of partial thread lugs 252 is a female ISO 80369-3 format tip and is thus a connector according to ISO 80369-3), and wherein a diameter (D11 in Fig. 5D) of the transmission portion is less than a diameter of the proximal cavity and a diameter (D9 in Fig. 5D) of the distal cavity (see annotated Davis drawing 1 above for cavities and para. 0061 – the diameter D11 of the transmission portion is smaller than both the diameter of the annotated proximal cavity and the diameter D9 of the distal cavity).
Regarding claim 17, Davis discloses (Claim 17) a cap (230 in Fig. 5A-5F) comprising:
a cylindrical section (body of 230) comprising a proximal end (240 in Fig. 5D) and a distal end (250 in Fig. 5D);
a proximal cavity comprising an inlet opening positioned within the proximal end (240 in Fig. 5D) of the cylindrical section (body of 230, see annotated Davis drawing 1 below for proximal cavity and inlet opening – the proximal cavity is being interpreted as the entire cavity form by the collar 244 of the proximal end 240 with the inlet opening being the proximal opening of said entire cavity);
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a distal cavity comprising an outlet opening positioned within the distal end (250 in Fig. 5D) of the cylindrical section (body of 230, see annotated Davis drawing 1 above for distal cavity and outlet opening);
a transmission portion positioned between the proximal cavity and the distal cavity (see annotated Davis drawing 1 above – the transmission portion is being interpreted as the portion having diameter D11), wherein the transmission portion connects the proximal cavity and distal cavity (see annotated Davis 1 drawing above);
a first connection element (internal threads of 244) positioned around an inner circumference of a walled section (244 in Fig. 5D) defining the proximal cavity (examiner notes the first connection element is being interpreted under 112(f) as a connection comprising features such as a snap, a hook, friction coupling, or equivalent structure, see annotated Davis drawing 1 above for proximal cavity, Fig. 5D and para. 0059 – the threads of wall section 244 are being interpreted as equivalent structures to a snap, hook, or friction coupling for connection); and
a second connection element (252 in Fig. 5A) positioned on the distal end (250) of the cylindrical section (body of 230, see Fig. 5A and para. 0060 – the pair of partial thread lugs 252 are being interpreted as the second connection element as they form a threaded engagement), wherein the distal end (250) with the second connection element (252 in Fig. 5A) is configured for direct connection to an enteral line (see para. 0060 – the pair of partial thread lugs 252 engage directly with a male ENFIT tip of a syringe as seen in Fig. 2 indicating direct connection to an enteral line), and wherein the second connection element (252 in Fig. 5A) is a connector according to ISO 80369-3 (see para. 0060 – the distal end 250 having the pair of partial thread lugs 252 is a female ISO 80369-3 format tip and is thus a connector according to ISO 80369-3), and wherein a diameter (D11 in Fig. 5D) of the transmission portion is less than a diameter of the proximal cavity and a diameter (D9 in Fig. 5D) of the distal cavity (see annotated Davis drawing 1 above for cavities and para. 0061 – the diameter D11 of the transmission portion is smaller than both the diameter of the annotated proximal cavity and the diameter D9 of the distal cavity).
Regarding claim 30, Davis discloses (Claim 30) the cap (230 in Fig. 5A-5F) of claim 14, wherein the proximal end (240 in Fig. 5D) and the distal end (240 in Fig. 5D) of the cylindrical section (body of 230) define an axial direction extending between them (see Fig. 5D and para. 0060 – the axial direction is in the direction of the lengthwise axis X), and wherein the transmission portion is positioned between the proximal cavity and the distal cavity along the axial direction (see annotated Davis drawing 1 above).
Regarding claim 31, Davis discloses (Claim 31) the cap (230 in Fig. 5A-5F) of claim 17, wherein the proximal end (240 in Fig. 5D) and the distal end (240 in Fig. 5D) of the cylindrical section (body of 230) define an axial direction extending between them (see Fig. 5D and para. 0060 – the axial direction is in the direction of the lengthwise axis X), and wherein the transmission portion is positioned between the proximal cavity and the distal cavity along the axial direction (see annotated Davis drawing 1 above).
Regarding claim 32, Davis discloses (Claim 32) the cap (Fig. 5A-5F) of claim 30, wherein the distal cavity terminates at the transmission portion (see annotated Davis drawing 1 above – the annotated distal cavity terminates at its proximal end at the transmission portion defined by diameter D11).
Regarding claim 33, Davis discloses (Claim 33) the cap (Fig. 5A-5F) of claim 31, wherein the distal cavity terminates at the transmission portion (see annotated Davis drawing 1 above – the annotated distal cavity terminates at its proximal end at the transmission portion defined by diameter D11).
Regarding claim 34, Davis discloses (Claim 34) the cap (see Fig. 5A-5F) of claim 14, wherein the proximal cavity, the transmission portion, and the distal cavity define a channel through the cap (see annotated Davis Drawing 2 below – the dotted line annotated below illustrates a channel through the cap), wherein the channel is configured to flow a nutritional composition through the cap from the inlet opening to the outlet opening (see annotated Davis Drawing 2 below and para. 0060 – the cap in Fig. 5A-5F is configured to allow fluid communication between the first end 240 and its inlet opening and the second end and its outlet opening and thus is capable of being
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configured to flow a nutritional composition from the inlet to outlet opening).
Regarding claim 35, Davis discloses (Claim 35) the cap (see Fig. 5A-5F) of claim 17, wherein the proximal cavity, the transmission portion, and the distal cavity define a channel through the cap (see annotated Davis Drawing 2 above – the dotted line annotated below illustrates a channel through the cap), wherein the channel is configured to flow a nutritional composition through the cap from the inlet opening to the outlet opening (see annotated Davis Drawing 2 below and para. 0060 – the cap in Fig. 5A-5F is configured to allow fluid communication between the first end 240 and its inlet opening and the second end and its outlet opening and thus is capable of being configured to flow a nutritional composition from the inlet to outlet opening).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Salazar-Leal (U.S Patent No. 6929136 B2).
Regarding claim 15, Davis discloses the cap of claim 14, as discussed above. However, Davis fails to disclose (Claim 15) wherein the cap is manufactured from a material responsive to a parameter of a substance that contacts the cap.
Salazar-Leal discloses a cap for a beverage container; however, the cap would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of caps for enteral feeding devices. Salazar-Leal teaches (Claim 15) wherein the cap is manufactured from a material responsive to a parameter of a substance that contacts the cap (see Col. 1, lines 43-53 – the cap of a beverage container is a plastic composition admixed with a thermochromic material that is visually altered when the cap is exposed to certain temperatures, see Col. 3, lines 10-15 – the color of the cap may change in response to the internal temperature of the contents of the container).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap material taught by Davis to incorporate the thermochromic material of Salazar-Leal. The motivation for this modification is that Salazar-Leal teaches a monochromic cap for use in beverage containers as a means to visually sense the temperature of the contents and as an expression of creativity and higher attractive value from color-effect (see Col. 2, lines 36-43). Examiner notes visually sensing the temperature of enteral nutrients is an obvious advantageous modification and visual attraction would be an obvious advantage for medical caps used in pediatric populations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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