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.
Claim(s) 11-38 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. 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.
Regarding Claims 11 and 30 (and numerous dependents), Applicant recites “one or more semi-annular projections extending radially inward from the c-shaped proximal end region”. However, based upon the understood meaning of “semi-annular projections” it is believed that this constitutes new matter inasmuch as Applicant does not provide any support for considerations of a single semi-annular projection in contrast to the segmented semi-annular projection disclosed (see 47 – Fig. 2). Specifically, the instant disclosure does not suggest that the collar can be continuous and the instant disclosure has not been demonstrated to be operational if supplied with a continuous collar. Specifically, as would be generally understood by the ordinary artisan, a segmented collar would provide for increased flexibility while the syringe needle shield is passed through the collar since each notch within the collar would provide a point where the collar could flex while distributing stress on the collar through the gaps thereby allowing for more flexing of the collar without breakage (see the operation described in Par. 39 with respect to flexibility of the collar). While Applicant does reference these segmented sections collectively as a “collar” (47) in the singular, the specification of U.S. Patent No. 11,980,744 (of which the instant claims are copies) is suggestive that the “one or more semi-annular projections” might be best understood as a continuous collar (1.4 – i.e. a single semi-annular projection) or, alternatively, a plurality of shoulder sections equivalent to Applicant’s segmented collar (see Col. 11, Ln. 35-40; see also generally Fig. 4).
Regarding Claim 23, here Applicant recites “wherein the one or more semi-annular projections is a single semi-annular projection”. However, Applicant has not demonstrated possession of such an invention based on the understood metes and bounds of the terminology as reflected in the ‘744 disclosure. Specifically, the “single” semi-annular projection would be, in light of the ‘744 disclosure, understood to exclude a segmented projection and would require a singular continuous projection (see Fig. 32, projection 1.4 of the ‘744 disclosure). Applicant does not provide support for any such arrangements nor has Applicant afforded any consideration as to whether such a configuration would even be possible with respect to the disclosed invention or if a segmented collar is essential, as understood by Applicant’s disclosure, for affecting sufficient flexibility to the distal collar to allow the rigid needle shield to pass through the collar, particularly without fracturing or damaging the collar.
Regarding Claims 24 and 28, Applicant recites “the rigid needle shield has an outer diameter substantially equal to an outer diameter of the barrel of the syringe”. However, support for this limitation could not be found in the originally filed detailed disclosure and in fact the instant disclosure is only evidence in consideration wherein the tubular needle shield has an outer diameter which is “larger than the outer diameter of the syringe” (Par. 9, see also Par. 37). While “substantially equal” does establish a genus which includes species where the rigid needle shield is nominally larger than the outer diameter of the syringe barrel it also provides for support of arrangements where the two diameters are equal and arrangements where the rigid needle shield diameter is nominally smaller than the syringe barrel – embodiments which are contradictory to Applicant’s explicitly disclosed arrangements. While, to a certain extent, originally filed figures can be relied upon to demonstrate a presumed scale, consideration of these figures must be made with concern to the instant disclosure and given that these claims are copies of the ‘744 patent and that the instant claim is clearly made in response to those issued in the ‘744 patent a strict consideration of support for this limitation must be made. Given that this limitation explicitly contradicts the only particularly resolved arrangements of the shield and syringe body diameter, it must be held that Applicant’s disclosure fails to demonstrate possession of the claimed subject matter and Claim 24 is therefore new matter.
Regarding Claims 29 and 33, Applicant recites the limitation “a circumferential region of the syringe carrier between the first and second protrusions is free of radial protrusions”. However, Applicant does not appear to have support for this arrangement. Specifically, even presuming, arguendo, that it is proper to consider the distal collar/flange to include two distinctive “radial protrusions” based on the extent to which the front and rear sides of the flange project further radially outward as compared to the truncated/flatted left and right sides (see Fig. 1) it would not be found proper to characterize the left or right sections as being “free” of radial protrusions (at least not as understood in view of the ‘744 disclosure). The instant flange/collar is shown being continuous wherein the left and right protrude LESS than the front and back, but still do protrude (see Fig. 1) – see also the manner in which the syringe flange is explicitly characterized in Claim 30 of the instant application, i.e. “a second portion that extends radially outward a second distance in a direction that is perpendicular to the first direction, the first distance being greater than the second distance”. Examiner submits that there is no way to consistently interpret the flange of the syringe to have such radial extension while suggesting that the flange/collar of the carrier does not have a “protrusion” between the front and rear sides (see Fig. 1).
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) 11-38 is/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.
Regarding Claims 11 and 37, Applicant recites the limitation “the elongate body defining… a window for allowing visual access to the barrel of the syringe”. However, based on the current specification it is unclear to what extent this “window” is distinguished from the previously claimed “slot”. Specifically, the specification only explicitly discusses a “window” with respect to the “autoinjector housing” (see Par. 25, 41 – see element 15 defined within housing 10 – Fig. 3a) wherein this window overlies the slot to permit visualization of a retained syringe barrel within the elongate body. Views of the elongate body are limited with respect to the side reverse of the slot and while there does appear to be some structure which might be a window (see Fig. 2, 3a – this structure is never discussed in the specification or particularly labeled and pointed out in the drawings. As such, any potential reader of the specification and claims is likely to be confused as to the metes and bounds of this “window” and determining how this “window” is distinctive from the “slot” (as disclosed). This is of particular importance since the specification of U.S. Patent No. 11,980,744 – to which the instant claims are substantially copied does make a clear distinction between “windows” and the “slot” (see Col. 8, Ln. 59-62). To the extent that the instant claims are copies of the ‘744 and intended to invoke an Interference Proceeding the interpretation of “window” must be consistent with this disclosure of the ‘744 patent as opposed to some alternative interpretation of “window”.
Regarding Claim 11, Applicant recites the limitation “one or more semi-annular projections”. However, this terminology is not used in the originally filed detailed disclosure and creates confusion as to exactly what structure(s) are to be covered by the terminology. The term “semi-annular” is not a particularly well-defined term, but may generally understood as the prefix “semi” modifying the term “annular”, where “annular” is defined as “of, relating to, or forming a ring”, see Merriam-Webster’s Online Dictionary, and the prefix “semi” may be understood as, in a strict sense, “precisely half-of…”, or “half in quantity or value…”, see Merriam-Webster’s Online Dictionary, or in a broader sense “to some extent : partly : incompletely” and “partial : incomplete”, or “having some of the characteristics of”, see Merriam-Webster’s Online Dictionary. Looking at Applicant’s specification, there is a “collar (47)” shown as a collective number of segmented sections (see Fig. 2 – showing four sections) which collectively form a C-shaped arrangement which extends substantially more than half of a circle. In contrast, the disclosure of the ‘744 patent does show a projection which is formed as a half-circle (see Fig. 4) including an arrangement with two of such half-circle projections (see Fig. 4) although, presuming the ‘744 meant “semi-annular” in the strict sense, then this would not define “one or more semi-annular projections extending radially inward from the c-shaped distal end”, since at best each semi-annular projection is coextensively defined in combination with its own c-shaped distal end section (see Fig. 4). As such, it is presumed that the ‘744 patent intended “semi-annular” to be the broader case where the projections define part of, but less than a whole, or a circle/ring (see Fig. 32 in association with Col. 11, Ln. 35-40).
However, in the instant case Applicant uses the terminology “collar” (in the singular) to reference the plurality of partially annular segments (see Fig. 2 – note the use multiple reference numerals 47). While Examiner submits that this could be considered to comprise one, segmented semi-annular projection OR a plurality of semi-annular projection segments, it cannot be interpreted BOTH ways, such that the meaning of “one or more semi-annular projections” is unclear in the context of the instant specification. Based on the disclosure of the ‘744 patent it would be generally understood that the disclosed arrangement of the instant disclosure constitutes an plurality of semi-annular projections and there is no configuration disclosed which resolves a singular ONE semi-annular projection (i.e. a continuous c-shaped projection compare Fig. 32 of the ‘744 patent to Fig. 2 of the instant invention).
Regarding Claim 24, Applicant recites the limitation “substantially equal”. In the instant case the specification provides no antecedent basis for “substantially” and ALL explicitly disclosed embodiments present with the rigid needle shield having a diameter which is LARGER than that of the syringe barrel (see e.g. Par. 9 and 37). As such, the metes and bounds of “substantially” are indefinite in this case.
Regarding Claim 28, Applicant recites the limitation “a first radial protrusion and a second radial protrusion”. However, such “radial protrusions” are not identified in the instant specification. The instant specification does provide support for the carrier to comprise a flange/collar with only one line of symmetry such that the front side and the rear hand side protrude more than the left or right (see Fig. 1), but Examiner does note that this flange is still continuous about the circumference of the carrier in contrast to the conspicuous protrusions illustrated in the ‘744 invention (see e.g. Fig. 32 and 33). In the instant case it is unclear whether it is reasonable to characterize this flange as having two “radial protrusions” or if this would be more properly considered a singular, circumferential protrusion with an inconsistent diameter.
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 –
(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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
Claim(s) 11-38 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Publication No. 2020/0405960 (“Hourmand”).
Regarding Claim 11-38, to the extent that the instant claims are substantially copied from those of the ‘744 patent (i.e. the issued patent corresponding to the ‘960 Houmand Pre-Grant Publication) and the instant claims include subject matter which is not found to be supported by the instantly filed detailed disclosure, the claims are rejected as being anticipated by the ‘960 PGPUB disclosure of Hourmand, the instant claims only being afforded the effective filing date of 15 May 2024 (see rejection(s) made under 35 USC 112(a) above which establish the filing date to be the actual filing date of the instant application and not the claimed priority date).
Claim(s) 11-38 is/are rejected under pre-AIA 35 U.S.C. 102(g) as not being timely filed over U.S. Publication No. 2020/0405960 (“Hourmand”).
Regarding Claim 11, this claim corresponds to Claim 18, as published, in Houmand.
Regarding Claim 30, this claim corresponds to Claim 27, as published, in Hourmand.
These claims were published on 31 December 2020, but Applicant did not file the instant application until 15 May 2024.
Claims 12-29 and 31-38 are likewise rejected under 35 USC 102(g) based upon the presence of Claims 11 and 30 whereby a lack of demonstrated timeliness for the independent claims establishes a lack of timeliness for the invention as whole.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 11-29 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 31 and 35 of U.S. Ser. No. 18/363,575. Although the claims at issue are not identical, they are not patentably distinct from each other. A Notice of Allowance was mailed for the reference application on 30 April 2026 and the issue fee was paid on 14 July 2026.
Regarding Claim 11, ‘575 claims (see Clm. 35):
a syringe carrier (Clm. 31) comprising:
an elongate body defining a recess configured to receive a barrel of a syringe (see Clm. 31 – re: “configured to allow a syringe to be inserted through the collar, the elongate body configured to receive a barrel of the syringe), the elongate body defining
(i) a slot extending distally from a proximal end of the elongate body such that the elongate body has a c-shaped proximal end region (see Clm. 31) and
(ii) a window for allowing visual access to the barrel of the syringe when the syringe is in the syringe carrier (see Clm. 35); and
one or more semi-annular projections extending radially inward from the c-shaped proximal end region of the elongate body (see Clm. 31 – re: “wherein the c-shaped proximal end region of the elongate body comprises at least one inwardly extending projection…”), wherein the c-shaped proximal end region of the elongate body is configured to flex radially outward as a rigid needle shield of the syringe is slid in an axial direction along the one or more semi-annular projections extending radially inward from the c-shaped proximal end region and to rebound radially inward when a distal end of the rigid needle shield has moved proximal to the one or more semi-annular projections, and the one or more semi-annular projections is configured to be disposed in a gap between the barrel of the syringe and the rigid needle shield when the distal end of the rigid needle shield has moved proximal to the one or more semi-annular projections (see Clm. 31).
Dependent Claims 12-29 are found to describe nominal features which do not present any particular contribution over Claim 35 of the reference application, presenting only nominal and obvious variations to the claimed subject matter.
Conclusion
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 08/27/2026
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