DETAILED ACTION
The preliminary amendment filed January 3, 2025 has been entered. Claims 9-21 remain pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112, sixth paragraph.
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.
Claim 17 is 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 17 recites the limitation "the groove" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 introduces a “groove feature,” but it is unclear if the groove of claim 17 is a reference to the groove feature of claim 11 or an additional groove. Further, claim 17 does not depend from claim 11. Claims 9 and 16, from which claim 17 does depend, do not recite a groove.
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.
Claims 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,389,377 (the ‘377 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 9-20 are recited by or obvious in view of claims 1-6 of the ‘377 patent. Regarding claims 9-12, all of the limitations are recited by claim 3 of the ‘377 patent. Regarding claims 13-15, all of the limitations are recited by claims 4-6 of the ‘377 patent and it would be obvious to one of ordinary skill in the art to include these features with the device of claim 3. Regarding claims 16-17, the claims of the ‘377 patent do not recite the cradle housing is cylindrical and the groove is parallel to the axis of the housing. However, it would have been obvious to one of ordinary skill in the art to form the housing as cylindrical and the groove parallel to the axis, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(B). Choosing a desired shape is a matter of design choice which does not significantly alter operation of the device and cylindrical shapes are known in the art (see the prior art rejection below for evidence of this finding). Regarding claims 18-19, the claims of the ‘377 patent do not explicitly recite a second groove and second bar. However, the claims recite “at least one groove” and “at least one orientation bar” which means that in at least one embodiment of the claims, more than one groove and more than one orientation bar is present. Therefore, these limitations are either inherent to or obvious in view of claim 3 of the ‘377 patent. Claim 20 depends from claim 19 and the limitations thereof are recited by claim 3 of the ‘377 patent. Therefore, in making or using the apparatus of claims 1-6 of the ‘377 patent, one of ordinary skill in the art would make or use the inventions of claims 9-12 and 18-20 and the inventions of claims 13-17 would be obvious to one of ordinary skill in the art based on claims 1-6 of the ‘377 patent combined with the knowledge of one of ordinary skill in the art.
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 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.
Claims 9, 11, and 15-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Patent 3,094,989 to Stauffer (Stauffer).
Regarding claim 9, Stauffer discloses filling aid (the device as shown in Figs. 1-3 can be used to aid filling) comprising: a needle housing portion (body 11 serves as a housing for needle 15; see Fig. 1) defining an interior opening (the interior space of housing 11) and having an exterior surface (the outer surface of body 11); and a filling needle cradle (see Figs. 1-3; the housing portion holding body 11 can be considered a needle cradle) comprising an outer cradle housing (sleeve 10) and a filling needle (15), the filling needle cradle slidably movable along the exterior surface of the needle housing portion from a starting position (slidable movement shown in Figs. 1-2; Fig. 1 shows the starting position) to a filling position (Fig. 2), the filling needle cradle further comprising an orientation bar (formed by 21 and 21a) extending from the cradle outer housing to the needle (see Fig. 1; the bar extends between the sleeve 10 and the lower portion of needle 15), whereby the needle is positioned in the interior opening of the needle housing portion (Fig. 1).
Regarding claim 11, Stauffer discloses the needle housing portion further defines a groove feature (the upper opening of body 11 though which the needle extends in Fig. 2 can be considered a “groove feature”).
Regarding claim 15, Stauffer discloses a filling aid base (pedestal 16) whereby the needle housing is releasably engageable to the filling aid base (body 11 is releasably coupled to pedestal 16 by sleeve 10).
Regarding claim 16, Stauffer discloses the needle housing is cylindrical and the cradle housing is cylindrical (both sleeve 10 and body 11 are described as cylindrical; col. 2, lines 20-32).
Regarding claim 17, Stauffer discloses the cylindrical needle housing defines an axis (longitudinal axis of the sleeve 10) and the groove (the groove feature as described in claim 11) is parallel to the axis (Figs. 1-2; the longitudinal axis of the groove is parallel to the axis of the sleeve).
Regarding claim 18, Stauffer further discloses wherein the needle housing (11) defines a second groove feature (the groove by which cap 12 is connected to body 11; see Fig. 1).
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the cited documents do not disclose “The filling aid of claim 10 further comprising a filling aid base whereby the needle housing is releasably engageable to the filling aid base and the filling aid base flexes the tab between the starting position and the filling position.” The examiner finds no evidence that one of ordinary skill in the art would modify the cited documents to include such an arrangement, absent the teachings of Applicant’s disclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and claimed invention.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 December 11, 2025