Prosecution Insights
Last updated: September 18, 2026
Application No. 18/893,588

STERILE OR STERILIZED PACKAGE FOR ADMINISTRATION OF MEDICINAL OR NUTRITIONAL SUBSTANCES

Non-Final OA §103§DP
Filed
Sep 23, 2024
Priority
Feb 26, 2019 — IT 102019000002745 +1 more
Examiner
DEL PRIORE, ALESSANDRO R
Art Unit
Tech Center
Assignee
Adienne Pharma & Biotech SA
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
1y 6m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
125 granted / 204 resolved
+1.3% vs TC avg
Strong +45% interview lift
Without
With
+45.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
18 currently pending
Career history
229
Total Applications
across all art units

Statute-Specific Performance

§101
2.9%
-37.1% vs TC avg
§103
52.2%
+12.2% vs TC avg
§102
15.3%
-24.7% vs TC avg
§112
21.7%
-18.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 204 resolved cases

Office Action

§103 §DP
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 . Status of Claims Claims 1-12 are pending in the present application and are examined on the merits. 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: “openable closure element” in claim 1. 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. In the instant case, the “openable closure element” is interpreted as a “frangible closure”, as described in Applicant’s specification (Paragraph 17), 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 § 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 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. Claims 1-4, 7 and 12 are rejected under 35 U.S.C. 103 as being obvious over Gobbi Frattini (US 2016/0000650 A1), hereinafter Gobbi, in view of Eli et al. (US 2019/0142695 A1) and Rolle et al. (US 6,464,105 B1), all of which are cited in Applicant’s 10/25/24 or 8/19/25 IDS. Regarding claim 1, Gobbi teaches a package for administration of medicinal or nutritional substances (Fig. 1; Abstract) comprising: an outer bag (sterile casing 12 and 100) with a sterilized inner chamber (¶s 3, 55, and 61), a bottle of medicinal or nutritional substance (bottle 9) set in an overturned position and disposed within the inner chamber of the outer bag (Fig. 1), the bottle comprising a neck (best seen in Figs. 9 and 10) and a pierceable cap set in the neck (Figs. 1, 9, and 10, collar 20 and cap 60; Paragraphs 49 and 51-54), a device configured to withdraw or reconstitute of the substance contained in the bottle (Figs. 1, 9, 10, and 13-14; perforation device 8; ¶s 47, 49, and 59 describe how the device slides and perforates the cap), wherein the device comprises: an upper body having flaps hooked to the neck of the bottle (first element 21 and flaps 24 in Fig. 10; ¶ 51), and a lower body (second element 22) slidably coupled to the upper body (¶ 49), the lower body comprises: a perforation needle configured to move in an axial direction relative to the bottle and perforate the cap of the bottle (hollow tip 18 in Figs. 9 and 10; ¶s 54 and 59), and a bottom shank from a base of the needle (at least a portion of openable closure 7), and an outflow tube hermetically receiving the bottom shank and extending from the base of the needle (mixing tube 6; Figs. 1-3 show how the shank is sealed in the mixing tube; also see Paragraphs 19 and 45-48 which describe how the system is sealed to allow fluid to drain through tube 6), the outflow tube comprising an openable closure element disposed in a passage of the outflow tube (Fig. 3 shows how the device is broken and opened between shank 7 and tip 17; Paragraphs 48 and 54), wherein said perforation needle comprises: a first channel extending longitudinally through the perforation needle such that the first channel establishes fluid communication between an interior of the bottle and the passage of the outflow tube when the perforation needle perforates the cap and the closure element is opened (Figs. 9 and 10, channel 57; Paragraphs 54 and 59), wherein the base of the perforation needle extends below the upper body when the perforation needle is moved upward in the axial direction relative to the bottle and perforates the cap of the bottle (shown in Fig. 10). Gobbi does not explicitly teach a second channel establishing fluid communication between the inner chamber of the outer bag and the interior of the bottle, and a hydrophobic filter disposed in the second channel and within the base of the perforation needle to allow only gaseous fluid to flow through eh second channel. However, Eli teaches a vial adapter having a surrounding container with a source of sterile gas (Fig. 1, chamber 1040 and Fig. 23, adapter 10b; Abstract and Paragraphs 43, 58, and 109; also see Fig 17, regulation passageway 28 and Paragraph 173), thus being in the same field of endeavor, comprising second channel extending from a side opening of a perforation needle to a tip of the perforation needle (Fig. 1, regulation passageway 1028 and opening 1282 and Paragraph 83; also Fig 17. passageway 28 and ¶ 173), and a hydrophobic filter disposed in fluid communication with the second channel (¶ 150 and 151 describe how a hydrophobic filter can be used in regulation pathway 1028 to prevent passage of liquid therethrough; ¶ 150 explicitly indicates the filter may be arranged against openings or adjacent the chamber; ¶ 173 indicates Fig. 11 passageway 28 and portions 286, and 284 as the regulation pathway; a filter disposed in pathways any of the passageway portions 28, 286, and 284 would be interpreted as being within the perforation needle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gobbi to comprise the regulation pathway and hydrophobic filter of Eli. Further, doing so would be obvious as the sterile casing of Gobbi would function analogously as a source of sterile gas as described in Eli. Thus, the side opening would open directly into the inner chamber of the outer bag. Doing so would be obvious to one of skill who would be motivated to provide the advantage of allowing for equalization using sterilized air or other gases in the outer container and would be beneficial in allowing gases to pass through but preventing liquid from the vial from escaping (as described in ¶s 3, 5, 91, 110, and 151 of Eli; by definition and as described in Eli, the hydrophobic filter would also be configured to allow only gaseous fluid to flow between the interior of the bottle and the inner chamber of the bag). The combination of Gobbi and Eli still do not explicitly teach the hydrophobic filter being disposed in the second channel and within the base of the perforation needle. However, Rolle teaches a fluid transfer vial with pressure equalization (Fig. 5; Abstract), thus being in the same field of endeavor, comprising a perforation needle (hollow spike 10) with a first channel for establishing fluid communication with an interior of a bottle and a passage of an outflow tube when the perforation needle perforates a cap (channel 21; Col. 5, lines 55-62), a second channel establishing fluid communication between the interior of the bottle and an external source of gaseous fluid (additional channel 22), and a filter disposed in the second channel and within the base of the perforation needle (filter 23; Col. 5, lines 55-62). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second channel and filter of Gobbi and Eli such as to arrange the hydrophobic filter within the second channel and within the base of the perforation needle, as taught by Rolle. Doing so would allow for equivalent pressure equalization (Col. 5, lines 55-62 of Rolle) and would create a compact design. Further, rearranging the position of the filter to be disposed in the second channel and within the base of the perforation needle would have been within ordinary skill in the art, since this claimed positioning of the side opening not change its function in fluidly connecting the second channel to the source of gaseous fluid for equalizing pressure (disclosed in both Eli and Rolle). Since Applicant has not given any criticality to why the position of the side opening (Applicant’s specification appears to only state the location of the side opening without indicating criticality or unexpected results), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.04(VI)(C) which relates to Rearrangement of Parts. Limitations of the hydrophobic filter “allowing only gaseous fluid to flow through the second channel” and the base of the perforation extends below the upper body “when the perforation needle is moved upward in the axial direction relative to the bottle and perforates the cap of the bottle” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gobbi, Eli, and Rolle comprises all the structure as claimed. As such, the device would be configured to direct gaseous fluid to flow in the manner as claimed. Regarding claim 2, Gobbi further teaches the first channel extends longitudinally through the perforation needle (Figs. 9-10). Regarding claim 3, the combination of Gobbi, Eli, and Rolle substantially teaches the invention of claim 1. Rolle further teaches the second channel extends from a side opening of the perforation to a tip of the perforation needle (as seen in Figs. 5-7). As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second channel and filter of Gobbi and Eli such as to arrange the hydrophobic filter within the second channel and within the base of the perforation needle, as taught by Rolle. Doing so would thus comprise the side opening directly into the inner chamber of the outer bag. Doing so would allow for equivalent pressure equalization (Col. 5, lines 55-62 of Rolle) and would create a compact design. The combination does not explicitly teach the side opening is disposed at the base of the needle above the bottom shank and opens directly into the inner chamber of the outer bag. However, rearranging the position of the side opening of the perforation needle to be disposed at the base of the needle above the bottom shank would have been within ordinary skill in the art, since this claimed positioning of the side opening not change its function in fluidly connecting the second channel to the source of gaseous fluid for equalizing pressure (disclosed in both Eli and Rolle). Further, doing so would be obvious so as to not interfere with the frangible portion of Gobbi. Since Applicant has not given any criticality to why the position of the side opening (Applicant’s specification appears to only state the location of the side opening without indicating criticality or unexpected results), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.04(VI)(C) which relates to Rearrangement of Parts. Regarding claim 4, the combination of Gobbi, Eli, and Rolle substantially teaches the invention of claim 1. Rolle further teaches the second channel extends from a side opening of the perforation to a tip of the perforation needle (as seen in Figs. 5-7). As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second channel and filter of Gobbi and Eli such as to arrange the hydrophobic filter within the second channel and within the base of the perforation needle, as taught by Rolle. Doing so would thus comprise the side opening directly into the inner chamber of the outer bag. Doing so would allow for equivalent pressure equalization (Col. 5, lines 55-62 of Rolle) and would create a compact design. Further, doing so would be obvious as rearranging the position of the filter to be disposed in the side opening would have been within ordinary skill in the art, since this claimed positioning of the filter in fluidly connecting the second channel to the source of gaseous fluid for equalizing pressure (disclosed in both Eli and Rolle). Further, doing so would be obvious so as to not interfere with the frangible portion of Gobbi. Since Applicant has not given any criticality to why the position of the side opening (Applicant’s specification appears to only state the location of the side opening without indicating criticality or unexpected results), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.04(VI)(C) which relates to Rearrangement of Parts. Regarding claim 7, Gobbi further teaches the bag being made of a flexible material (¶ 3). Regarding claim 12, Gobbi further teaches a collection bag positioned below the outer bag and in fluid communication with the outer bag (Fig. 1, bag 2 ¶s 45 and 48). Claims 5-6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gobbi, Eli, and Rolle as applied to claim 1 above, and further in view of Pestotnik et al. (US 2007/0088252 A1), which is also cited in Applicant’s IDS. Regarding claim 5, the combination of Gobbi, Eli, and Rolle substantially discloses the invention of claim 1. They do not explicitly teach the outflow tube includes an end connector disposed at an end of the outflow tube and configured to open and close the end of the outflow tube. However, Pestotnik teaches an apparatus for sterile transfer of medications from a vial for dissolving or diluting said medication (Fig. 1; Abstract), thus being in the same field of endeavor, wherein an outflow tube from the vial terminates with an end connector disposed at an outflow end of the outflow tube and configured to open and close the end of the outflow tube (valve 14 and lock 16a; ¶ 20; ¶s 9 and 21 further describe the 3-way valve and valve handle system for opening and closing the connector). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outflow tube of Gobbi, Eli, and Rolle to comprise the end valve connector of Pestotnik (i.e. between the bags of Gobi). Doing so would be obvious to one of skill who would be motivated to provide the advantage of allowing for control over fluid flow out from the bottle/vial in the same manner as disclosed in Pestotnik (recognized in ¶s 10 and 21 of Pestotnik). Regarding claim 6, the combination of Gobbi, Eli, Rolle, and Pestotnik substantially teaches the invention of claim 3. Pestotnik further teaches the end connector is configured to be coupled to an opening of a syringe (Fig. 1 shows syringe 24). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the connector of Gobbi, Eli, Rolle, and Pestotnik specifically such that the end connector is configured to be coupled to a syringe. Doing so would be obvious to one of skill who would be motivated to provide the advantage of allowing for a solvent or other materials to be introduced and mixed with the contents of the bottle via s syringe (as described in ¶ 21 of Pestotnik). Regarding claim 9, the combination of Gobbi, Eli, and Rolle substantially teaches the invention of claim 1. Gobbi further teaches a second bag position below said outer bag and configured to contain a liquid substance to be mixed with said medicinal or nutritional substance (Fig. 1, bag 2 ¶s 45 and 48). The combination of Gobbi, Rolle, and Eli does not explicitly disclose a two-way tap disposed between said the outer bag and the second bag, the two-way tap comprising a side connector configured to be coupled to an opening of a syringe with a sliding plunger, said two-way tap is configured to be adjusted between a first position inhibiting fluid communication between the side connector and the second bag, and a second position inhibiting fluid communication between the side connector and the outflow tube of the outer bag. However, Pestotnik teaches a two-way tap placed between a bottle and a lower bag (Fig. 1, vial 20 and container 26, the bottle of Pestotnik corresponding to the function and position of the bottle and outer bag of Gobbi), thus being in the same field of endeavor, the two-way tap comprising a side connector configured to be coupled to a syringe with a sliding plunger (Fig. 1 shows syringe and plunger 24), wherein the tap is configured to be adjusted between a first position inhibiting fluid communication between said side connector and said second bag, and a second position inhibiting fluid communication between the side connector and the outflow tube of said outer bag (Paragraph 21 describes allowing flow from the bottle and syringe, thus inhibiting flow between the side connector and further bag, and flow between the syringe and lower bag, thus inhibiting flow between the side connector and outer bag). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outflow tube of Gobbi, Eli, and Rolle to comprise the two-way tap connector for inhibiting flow as taught by Pestotnik. Doing so would be obvious to one of skill who would be motivated to provide the advantage of allowing for selective control over fluid flow out from the bottle, and thus the mixing of components in the same manner as disclosed in Pestotnik (recognized in ¶s 10 and 21 of Pestotnik). Regarding claim 10, the combination of Gobbi, Eli, Rolle, and Pestotnik substantially teaches the invention of claim 9. Pestotnik further teaches the tap comprising a first connector secured to an end connector of an outflow tube, and a second connector secured to an end connector of a second outflow tube (Fig. 1, ports 12a, 12b, 12c, 16a, 16b, and 16c; ¶ 20 describes the various ports having lure locking devices which would attach to corresponding connectors on the vial, syringe, and other transferring devices). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combination of Gobbi Eli, Rolle, and Pestotnik to configure the two-way tap to be coupled to corresponding connectors of the outflow tube of the outer bag, and of a second outflow tube of the second bag, and to specifically comprise the connectors as taught by Pestotnik. Doing so would be obvious to one of skill who would be motivated to provide the advantage of allowing for secure fluidic connection and transfer between the various containers through the tap (as described in ¶s 20 and 30 of Pestotnik). Regarding claim 11, the combination of Gobbi, Eli, Rolle and Pestotnik substantially teaches the invention of claim 7. They do not explicitly teach the two-way tap is permanently secured to the outflow tube of the outer bag and a second outflow tube of the second bag. However, doing so would be obvious to one of skill who would be motivated to do so, since it has been held that making parts of a device separable or integral (i.e. separable or permanent connections) requires only routine skill in the art. See MPEP 2144.04 (V) which relates to making integral. In the instant case, making the connections of Gobbi, Eli, Rolle, and Pestotnik permanent is analogous to making the tap an integral part of the package system. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gobbi, Eli, and Rolle as applied to claim 1 above, and further in view of Gobbi Frattini (US 2017/0100307 A1), hereinafter Gobbi’307, which is also cited in Applicant’s IDS. Regarding claim 8, the combination of Gobbi, Eli, and Rolle substantially discloses the invention of claim 1. They do not explicitly teach the outer bag comprises a tube with an airtight connector configured to open and close to introduce a mixture of ozone or a sterilizing gas into the inner chamber of the outer bag. Gobbi’307 further teaches a package for administration of medicinal or nutritional substances (Fig. 1; Abstract), thus being in the same field of endeavor, comprising: an outer bag (sterile casing 2) with an airtight connector (connector 11) configured to open and close to introduce a mixture of ozone or a sterilizing gas into the inner chamber of the outer bag (¶s 30-35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Gobbi, Eli, and Rolle to comprise the connector of Gobbi’307. Doing so would thus comprise a tube with an airtight connector configured to open and close to introduce a mixture of ozone or a sterilizing gas into the inner chamber of the outer bag. Doing so would be advantageous in facilitating the introduction of ozone or other sterilized gas without needing a needle (recognized in Paragraph 30 of Gobbi’307). 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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-10 of U.S. Patent No. 12,097,168. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 2 of U.S. Patent No. 12,097,168 lies in the fact that the issued Patent claims includes more elements and is thus more specific. Thus, the invention of Patent No. 12,097,168 is in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Double Patenting Corresponding Claims Instant Application Claims 1, 2, 3, 4 Claim 5 Claim 6 Claim 7 Claim 8 Claim 9 U.S. Patent No. 10,973,962 Claim 2 Claim 3 Claim 4 Claim 5 Claim 6 Claim 7 Double Patenting Corresponding Claims Instant Application Claim 10 Claim 11 Claim 12 U.S. Patent No. 10,973,962 Claim 8 Claim 9 Claim 10 Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30. 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://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781 /GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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Prosecution Timeline

Sep 23, 2024
Application Filed
Aug 10, 2026
Non-Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
61%
Grant Probability
99%
With Interview (+45.2%)
3y 6m (~1y 6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 204 resolved cases by this examiner. Grant probability derived from career allowance rate.

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