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 .
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.
Election/Restrictions
Applicant’s election of Group I, Claims 1-9 and 12, in the reply filed on 18 March 2026 (“Reply”), is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Applicant should note that, as stated in the prior Action, Claims 10 and 11 are linking claims, and therefore are examined with the elected invention; they were not overlooked or forgotten.
Specification
The Abstract of the Disclosure (“Abstract”) is objected to because it includes legal phraseology (“comprising” at line 2, “comprises” at line 4). A corrected Abstract is required. See MPEP § 608.01(b). Any replacement Abstract must commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b), and include markings to show added and deleted text, 37 C.F.R. § 1.121(b)(2).
Claim Objections
Claims 1, 4, and 12 are objected to because of the following informalities.
Claim 1, at lines 2 and 4, recites the traditional transition phrase “comprising” twice; Claim 12, at lines 2, 4, and 5, recites the traditional transition phrase “comprising” three times. Because the preamble attempts to establish an unclaimed environment in which the claimed “adapter” is to function in a particular way, the multiple use of “comprising” invites confusion as to which is the true transition phrase for the claim. The Examiner suggests replacing the “comprising” at line 2 of Claim 1, and liens 2 and 5 of Claim 12, with “having” or “including” to make abundantly clear which is the actual transition phrase.
In Claim 4, line 7, “permitting” is misspelled.
Appropriate correction is required.
Claim Interpretation
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
It is currently the policy of the Office that, when a patent application references an industry standard, e.g., an ISO or IEEE standard, without identifying the version of that standard, it is presumed that the version of the referenced standard is the one that was in effect as of the earliest effective filing date of the application.
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: “rotation control mechanism” in Claim 4, which corresponds to elements 53c and 54b1.
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.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 reference the entire standard ISO 80369, which includes numerous subparts and amendments/corrections; however, the Specification makes clear that the inventors only conceived of devices which convert for devices which do not comply with only certain subsections of the standard, not devices which convert for devices which do not comply with each and every of the subparts. See ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements (www.iso.org/standard/64419.html). The passage in Applicant’s Specification at [0019] (“The above-described “luer lock-type male connector part conforming to ISO 80369” is intended to mean a luer lock-type male connector part conforming to ISO 80369-2 to ISO 80369-7.”) does not cure this defect, because it is not clear on the record that a single device can conform to all six of the subparts simultaneously.
Therefore, there is insufficient evidence in the record that the inventors had, as of the effective filing date of the application, possession of the entirety of the subject matters of Claims 1 and 12 (and, therefore, of Claims 2-11).
Claims 1-12 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.
See the discussion above with respect to sec. 112(a). The scopes of Claims 1 and 12 are also indefinite, because it is unclear if a device which conforms to some subparts of the standard, but not others, falls within the scope of the claim. For example, if a male connector and a female connector conform to different subparts of the standard, but don’t conform with each other’s, which is within the scope of the claim and which is not? Also, the term “non-compliant” in this context also makes the scope of the claim indefinite, because it is not clear if “non-compliant” means ‘not compliant with the entire ISO standard, or not compliant with just a portion of the standard. The passage in [0019] (“The above-described “luer lock-type male connector part conforming to ISO 80369” is intended to mean a luer lock-type male connector part conforming to ISO 80369-2 to ISO 80369-7.”) does not cure this defect, because it is not clear on the record that a single device can conform to all six of the subparts simultaneously. The broadest reasonable interpretation of the claims, with respect to that limitation, is therefore a device which conforms to any one subpart of the standard (for the preamble recitation), and a device which does not conform to any one subpart of the standard (for the body recitation), which is how they have been treated.
Claims 2-11 depend from Claim 1, inherit but do not cure its deficiencies, and are therefore also rejected.
Claim 8 only recites characteristics of the unclaimed “female connector part” with which the claimed adapter is intended to be used, and therefore the scope of the claim is indefinite, because it is unclear what is the effect on the scope of the positively recited elements in the bodies of Claim 5, 2, and 1. The claim has been treated as only modifying the preamble of Claim 1.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 only recites characteristics of the unclaimed “female connector part” which do not appear to affect the scope of the positively recited elements in the bodies of Claim 5, 2, and 1. Accordingly, Claim 8 does not comply with sec. 112(d), because it does not further limit Claim 5’s scope.
Applicant may: cancel the claim(s); amend the claim(s) to place the claim(s) in proper dependent form; rewrite the claim(s) in independent form; or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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, 2, and 5-12, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2017/0014616, by Davis et al. (“Davis”).
Davis describes a device as claimed by Applicant, as follows.
Claim 1: A conversion adapter attachable (Figs. 3A-3F) to a female connector part comprising (see treatment above) a male screw part to which a luer lock-type first male connector part conforming to ISO 80369 (see treatment above) is connectable, the conversion adapter comprising:
a female screw part (the internal threading in the coaxial connection collar (44) corresponds thereto; see Figs. 3A-F, [0055]-[0057]) screwable to the male screw part of the female connector part (id.; threads 44 are fully capable of receiving a male threaded device); and
a locking unit (50) configured to lock to a second male connector part not conforming to ISO 80369 (see treatment above; 50 is fully capable of locking with a male connector at 50).
Claim 2: (The conversion adapter according to claim 1,) comprising:
a cylindrical adapter body (Fig. 3D, unlabeled, hollow cylinder on the inner surface of which thread 44 is formed); wherein:
the female screw part is formed on an inner surface of the adapter body (same); and
the locking unit is formed on an outer surface of the adapter body (52).
Claim 5: (The conversion adapter according to claim 2,) wherein:
the female screw part of the adapter body is configured to be screwable to the male screw part of the female connector part until either
(i) a cylindrical part on which the male screw part is formed of the female connector part penetrates the adapter body in an axial direction, or
(ii) a distal end of the cylindrical part is flush with an inner edge of one end in the axial direction of the adapter body (for both (i) and (ii), their putative limitations depend on the unclaimed “male screw part of the female connector part;” Davis’s adapter’s female screw part is fully capable of being used as claimed).
Claim 6: (The conversion adapter according to claim 2,) wherein:
the female screw part of the adapter body is configured to be screwable to the male screw part of the female connector part until a cylindrical part on which the male screw part is formed of the female connector part penetrates the adapter body in an axial direction (this putative limitation depends on the unclaimed “male screw part of the female connector part;” Davis’s adapter’s female screw part is fully capable of being used as claimed).
Claim 7: (The conversion adapter according to claim 2,) wherein:
the female screw part of the adapter body is configured to be screwable to the male screw part of the female connector part until a distal end of the cylindrical part is flush with an inner edge of one end in the axial direction of the adapter body (this putative limitation depends on the unclaimed “male screw part of the female connector part;” Davis’s adapter’s female screw part is fully capable of being used as claimed).
Claim 8: (The conversion adapter according to claim 5,) wherein: the female connector part comprises: the cylindrical part, which defines an insertion opening into which a first male luer part of the first male connector part and a second male luer part of the second male connector part are externally insertable, and a valve element that blocks the insertion opening (claim does not further limit Claim 5, is rejected on the same grounds).
Claim 9: (The conversion adapter according to claim 1,) wherein:
the locking unit comprises a recess (portion of 50 longitudinally next to 52) engageable with a locking claw of the second male connector part (any unclaimed claw can “engage” the recess).
Claim 10: A connector set comprising:
the conversion adapter according to claim 1 (see above); and
a medical connector comprising the female connector part to which the conversion adapter is attachable ([0004], discussing using the connector with enteral feeding devices).
Claim 11: An assembly comprising:
the conversion adapter according to claim 1 (see above); and
the female connector part to which the conversion adapter is attached ([0004], discussing using the connector with enteral feeding devices).
Claim 12: A conversion adapter attachable to a female connector part comprising (see treatment above) a male screw part to which a luer lock-type first male connector part conforming to ISO 80369 (see treatment above) is connectable, the conversion adapter comprising:
a cylindrical adapter body comprising (see treatment above):
a female screw part (the internal threading in the coaxial connection collar (44) corresponds thereto; see Figs. 3A-F, [0055]-[0057]) formed on an inner surface of the adapter body (same) and screwable to the male screw part of the female connector part id.; threads 44 are fully capable of receiving a male threaded device), and
a locking unit (50, 52) configured to lock to a second male connector part not conforming to ISO 80369 (see treatment above; 50 is fully capable of locking with a male connector at 50), the locking unit being formed on an outer surface of the adapter body (52 is on the outside of the adapter body) and comprising a recess (portion of 50 longitudinally next to 52) engageable with a locking claw of the second male connector part (any unclaimed claw can “engage” the recess).
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.
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Davis as applied to Claim 2 above, and further in view of WO 2019/130891, by Kakinoki et al. (“Kakinoki;” English translation attached).
Davis describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
the adapter body comprises an inner cylindrical body comprising an inner cylindrical part on an inner surface of which the female screw part is formed, and an outer cylindrical body located on an outer side in a radial direction with respect to the inner cylindrical part, the outer cylindrical body comprising an outer cylindrical part on an outer surface of which the locking unit is formed (Claim 3); or
a rotation control mechanism is provided between the inner cylindrical body and the outer cylindrical body, the rotation control mechanism restricting relative rotation of the outer cylindrical body to one side in a circumferential direction of the adapter body with respect to the inner cylindrical body and permiting [sic: permitting] relative rotation of the outer cylindrical body to the other side in the circumferential direction with respect to the inner cylindrical body (Claim 4).
Kakinoki relates to medical, screw-type fluid adapters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Kakinoki teaches that such an adapter can be constructed in two nested cylindrical bodies, so that the overall device can be provided with a one-way clutch-like mechanism between the two bodies, to inhibit or prevent rotation of the adapter in a direction which would separate the adapter bodies (translation, pg. 5, first para.). More specifically, Kakinoki teaches constructing the adapter so that
the adapter body comprises an inner cylindrical body (22) comprising an inner cylindrical part on an inner surface of which the female screw part is formed (thread 60), and an outer cylindrical body (21) located on an outer side in a radial direction with respect to the inner cylindrical part (portions of 21 are radially outside of portions of 22, see Fig. 12), the outer cylindrical body comprising an outer cylindrical part on an outer surface of which the locking unit is formed (locking part 40, Fig. 12) (Claim 3); or
a rotation control mechanism (58, 46) is provided between the inner cylindrical body and the outer cylindrical body (Fig. 14), the rotation control mechanism restricting relative rotation of the outer cylindrical body to one side in a circumferential direction of the adapter body with respect to the inner cylindrical body and permitting relative rotation of the outer cylindrical body to the other side in the circumferential direction with respect to the inner cylindrical body (translation, pg. 17, second full para.).
It 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, to construct Davis’s medical fluid adapter with the foregoing features of Claims 3 and 4, because Kakinoki teaches doing so in a closely-related adapter, so that the overall device can be provided with a one-way clutch-like mechanism between the two bodies, to inhibit or prevent rotation of the adapter in a direction which would separate the adapter bodies.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
EP 2712652 describes a two-part medical fluid adapter similar to Applicant’s
The balance of the documents cited with this Office Action relate generally to medical fluid adapters.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern 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:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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