DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim(s) 12-26 is/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 and/or 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.
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 and/or the instant specification lacks antecedent basis for the claim terminology which creates confusion as to the scope of the instant claims, particularly in light of Applicant’s intent to provoke interference whereby the broadest reasonable interpretation of claim terminology is not to be determined by Applicant’s instant specification, but rather the specification from which the claims were copied, see Koninklijke Philips Electronics NV v Cardiac Science Operating Co (590 F3d 1326 (Fed Cir 2010) and In re Spina, 975 F2d 854 (Fed Cir 1992).
Regarding Claims 12 and 21, Applicant recites limitations directed toward “at least one projection extending radially inward form the proximal end of the elongate body”. While no specific “projection” is pointed out in the instant detailed disclosure this limitation is understood to refer to the collar (47). However, in the instant specification this collar, which referenced in the singular as “a proximal supporting collar” is illustrated in a segmented manner comprising a total of four segments distributed about the circumference of the collar.
However, the specification of the 11,511,043 reference patent from which the claims were substantially copied discloses two different manners in which their equivalent “shoulder” (1.4) may be formed. Specifically, the ‘043 reference patent illustrates that the collar may comprise a singular, continuous projection (see e.g. Fig. 32) OR that the number of shoulder sections “may be varied without departing from the spirit and scope of the invention”. Applicant’s instant disclosure would not appear to provide support for any configurations wherein the collar is formed of a unitary, singular projection, rather no fewer than four projections collectively determining the collar is disclosed. As such, Examiner submits that Applicant lacks support for a configuration of “at least one projection” since “one projection” (as understood in light of the ‘043 disclosure) is not disclosed by Applicant. Appropriate correction is required. Care should also be taken to consider amendments to the specification to provide proper antecedent basis for the claimed “projections” as understood in the context of the disclosure of the reference patent.
Regarding Claims 12 and 21, Applicant makes reference toward “a first radial protrusion” and “a second radial protrusion” and a “circumferential region between the first and second radial protrusions” which is “free of radial protrusions”, said protrusions comprising “two ribs that extend parallel to one another”. However, the instant specification is not understood to support such “protrusions”, particularly as understood in light of the disclosure of the ‘043 reference patent. Specifically, the reference patent discloses two discrete protrusions or ribs (1.60, 1.62) provided at their identified “proximal” end (corresponding to Applicant’s identified “distal” end). In contrast to the “distal supporting collar 49” of Applicant’s disclosed invention these “ribs” identified by the reference patent are formed such that they do no circumferentially adjoin with one another (see Fig. 32 and 33) such that they are discrete from one another with gaps separating them in the front (see Fig. 32) and rear (Fig. 33) of the syringe barrel. As such, Applicant’s instant disclosure does not provide any structure which might fairly be identified as such “first” and “second” “radial protrusions”, particularly ones identifiable as “two ribs that extend parallel to one another”. As such, it must be understood that either Applicant lacks written description support for the claimed subject matter or has set a confusing standard for establishing the scope of the claims wherein the scope of what Applicant may or may not consider to comprise their “ribs” and “protrusions” is NOT consistent with the specification from which the instant claims were substantially copied.
Regarding Claims 12 and 21, Applicant recites “a recess adjacent the slot, wherein the recess facilitates radial deflection of the elongate bod”. However, no such “recess” is identified in the instant specification, particularly one identified as “adjacent”. Firstly, it is noted that the term “adjacent” is a nebulous term that can mean “not distant : NEARBY”, “having a common endpoint or border”, or “immediately preceding or following”, see Marriam-Webster’s Online Dictionary. While Applicant’s figures illustrate a number of features which might be considered “recesses” (see below) which of these recesses might be considered “adjacent” to the “slot” (48) is not made clear by the specification. Specifically, the most proximal and distal identifiable recesses are unitarily formed with respect to the slot such that they are not discrete. It is unclear, based on Applicant’s disclosure as to whether these recesses should or should not be considered to be part of the slot or distinctive from the slot and therefore “adjacent” to the slot.
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Secondly, the ‘043 reference patent identifies a recess (1.17) that is particularly identified as a “hinge” which assists in the body to “radially deflect (e.g. rotate) about the groove hinges 1.17”. While in Applicant’s disclosure the “distalmost” recess (see above) corresponds in general location to the recess of the ‘043 patent it is not disclosed to provide the function of assisting radial deflection and it is unclear if it would or would not inherently perform as such. Likewise, the “proximalmost” recess (see above), which similar in structure to the reference patent’s hinge (despite being provided at an opposed location along the longitudinal axis) is likewise never disclosed as assisting deflection of the elongate body. As such, it must be fairly deemed that Applicant’s disclosure lacks written description support for the function of such recesses.
Regarding Claims 12 and 21, Applicant recites “a window proximal to the collar” with “a first projection that extends along an edge of the window”. However, no such “windows” are disclosed or clearly illustrated in Applicant’s disclosed invention. The only mention of a “window” in Applicant’s disclosure is made with respect to a “window 15” provided in the housing of the injector, not in the carrier (see Par. 40). In contrast, the reference patent discloses “In an exemplary embodiment, viewing windows (not shown) may be arranged in the body 1.1 for allowing visual access to the barrel 2.1 of the syringe 2 when the syringe 2 is in the syringe carrier 2. In an exemplary embodiment, the windows are formed as cut-outs” and that “Likewise, all the illustrated embodiments may be implemented with or without viewing windows 5…” As such, the reference patent makes it clear that the “viewing windows” are clearly distinctive from the slot. In contrast, Applicant’s disclose only dislcoses the function of the slot itself to be alignable with the window of the housing to permit viewing of the syringe (see Par. 40). Applicant discloses a “snap-fitting fastening means” (43) arranged on the carrier wall with a projection extending along an edge thereof, but this is not disclosed as comprising a through-going opening to create a window, not is such a feature clearly and unambiguously shown. Furthermore, even if this “snap-fitting fastening means” to create a through going opening, this opening would not perform the function of a “window” because it does not align with the housing in a manner to permit visualization of the retained syringe (rather the snap fitting fastening means is blocked by the housing – see Fig. 3b and 3C).
Regarding Claims 13 and 23, reference toward the “at least one projection” is rejected for the reasons set forth above.
Regarding Claim 15, reference toward the “at least one projection” comprising a “single projection” is likewise rejected inasmuch as Applicant would not appear to have written description support for a “single projection” as understood in light of the disclosure of the reference patent.
Regarding Claims 16 and 24, Applicant recites the limitation “the outer diameter of the rigid needle shield is substantially equal to an outer diameter of the barrel of the syringe”. However, the originally filed detailed disclosure makes absolutely no comparison between the diameters of the needle shield and barrel of the syringe, particularly a disclosure which would provide sufficient context to what is or is not “substantially equal”. As such, the claim limitation is rejected under BOTH 35 USC 112 first and second paragraph.
Regarding Claim 17, reference toward the “at least one projection” is likewise rejected for the reasons set forth above.
Regarding Claims 20 and 26, reference toward “the window” and its function is likewise rejected for the reasons set forth above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 12-26 is/are rejected under pre-AIA 35 U.S.C. 102(b) and/or pre-AIA 35 U.S.C. 102(e) as being clearly anticipated by U.S. Patent No. 11,511,043 (“Hourmand”).
Regarding Claims 12-26, these claims are substantially copied from those issued in the ‘043 patent (excluding a difference in the proximal/distal convention which does not alter the scope of the claims). However, as noted above the instant claims do not enjoy written description support from the original filing of the 61/570,921 priority document and therefore can be afforded a filing date no earlier than 28 November 2023 (the actual filing date of the instant application). Hourmand issued on 29 November 2022 and was previously published on 11 November 2021 as U.S. Publication No. 2021/0346604 and enjoys domestic priority of 05 December 2012 (see US 14/362,537 which is a National Stage Entry of PCT/EP2012/074466) and foreign priority of 08 December 2011 (see EP11192585.5). As such, these instant claims are rejected based on the earlier publication and filing of the Hourmand reference.
Response to Arguments
Applicant's arguments appear to acquiesce to the rejections made under 35 USC 112 (see Pg. 10-11) and therefore the instant rejection is made final.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/20/2026