Detailed Action
This office action is for US application number 18/680,669 evaluates the claims as filed on May 18, 2026 via the RCE filing of May 27, 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18, 2026 via the RCE filing of May 27, 2026 has been entered.
Response to Arguments
Applicant's arguments filed May 18, 2026 via the RCE filing of May 27, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Greter, Long, Jonsson, Sasaki, Greter’930, and Vogt teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that an English translation of the foreign priority application is generally not required and only required in limited circumstances under 37 CFR 1.55(g)(3) and Applicant is not aware of any circumstances that would require translation in this case (Remarks p. 5), Examiner notes that non-English language is unable to be considered; thus, an English language translation is required in accordance with 37 CFR 1.55(g) per MPEP 215 and MPEP 216. As provided by 37 CFR 1.55(g) in MPEP 215 “(3) An English language translation of a non-English language foreign application is not required except: (i) When the application is involved in an interference (see § 41.202 of this chapter) or derivation (see part 42 of this chapter) proceeding; (ii) When necessary to overcome the date of a reference relied upon by the examiner; or (iii) When specifically required by the examiner. Further, MPEP 216 provides that “If the certified copy is not in the English language and there is no translation, the examiner may reject the unpatentable claims and at the same time require an English translation (the translation must be that of the certified copy (of the foreign application as filed) that is submitted together with a statement that the translation of the certified copy is accurate) for the purpose of determining the applicant’s right to rely on the foreign filing date.”. Thus, a translation has been appropriately required.
With regards to Applicant’s argument that the claimed device configured with an inner diameter of less than 5 mm to retain the liquid in the collection region and to dispense the liquid only when a pressure difference is applied between the collection region and the second interior is not shown or suggested (Remarks p. 6), Examiner notes, that as detailed in the rejections below and those of the final office action dated March 26, 2026, such is obvious in light of the disclosures of Greter and Jonsson in view of Greter as Greter specifically discloses that the channel functions to receive some of the liquid component prior to activation of a negative pressure device by means of the different height of the liquid and gas expansion pressure (Greter ¶38) and to deliver the rest of the liquid component upon activation of the negative pressure device (Greter ¶39) and Jonsson specifically discloses that to permit feeding of the bone cement components, i.e. liquid, from the collection region of the ampule breaker, the cartridge is required to be connected to an active vacuum source (col. 5 lines 49-53).
With regards to Applicant’s argument that in Applicant’s device the control is achieved by designing the channel with a specific geometry and a small inner diameter to create a stable meniscus (Remarks p. 6), Examiner notes that a “specific geometry” has not been identified nor has such been claimed. Further, the ability to create a stable meniscus has not been claimed nor has a liquid with properties that would function to form such a meniscus when used with the claimed structure.
With regards to Applicant’s argument that the cited references all teach uncontrolled release and asserts that Greter is explicitly designed for immediate partial flow upon breaking the ampule as disclosed in paragraph 38 (Remarks p. 6), Examiner notes that, as provided in Applicant’s remarks, Greter paragraph 38 discloses that the transfer of the component 5 takes place by means of a different height of the liquid in chambers 3 and 1. That is, the transfer of component 5, i.e. the liquid, is due to the pressure difference in chambers 3 and 1, i.e. the ampule breaker 3 and the cartridge 1, as claimed. In addition, Greter paragraph 38 also discloses that “A residual gas volume is provided above the component 5 in the component container 4. When the component container 4 is opened, or when the container head 10 is broken off, the gas expands such that, owing to the expansion, a pressure is exerted on the component 5 and the latter is pushed into the feed line 8.”. That is, when the ampule 4 is opened, a pressure is exerted on the component 5 due to the gas in the ampule breaker 3.
With regards to Applicant’s argument that the subsequent application of negative pressure is only to transfer the remaining liquid and thus Greter is not “arranged and configured to retain the liquid” and dispense “only” with application or pressure as claimed but is arranged to allow immediate flow (Remarks p. 6-7), Examiner notes that there appears to be a disconnect between this argument, the disclosure or Greter, and the claim limitation. To start, it is unclear how one can reasonably assert that there is a subsequent application of negative pressure to transfer the remaining liquid as support for one’s assertion that such cannot retain liquid. That is, it is unclear how Applicant is proposing that such does not retain liquid but yet necessitates application of negative pressure to transfer the remaining liquid as it appears that if no liquid were retained, then there would be no reason to apply an additional pressure to transfer remaining liquid as there would be no remaining liquid if none were retained. With regards to Applicant’s argument regarding immediate flow, there is no limitation that precludes a device that permits immediate flow with pressure from reading on the claimed invention as is obvious in view of Greter as disclosed in paragraph 38 as cited by Applicant. Further, it appears that Applicant’s is arguing that the claimed device permits only a delayed flow with an unspecified amount of delay; however, this is not claimed. Instead, Applicant has claimed that “the fluid-conducting channel is arranged and configured with an inner diameter of less than 5 mm to retain the liquid in the collection region and to dispense the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior.” That is, it appears that Applicant is intending a particular delay in the presence of a pressure difference; however, such is not claimed.
With regards to Applicant’s argument that the inner diameter is less than 5 mm is the feature that prevents liquid from partially mixing in the second chamber as in Greter and only dispenses with pressure (Remarks p. 7), Examiner notes that such is capability is dependent upon an unclaimed size of molecules of an unclaimed liquid for an unclaimed amount of retention for an unclaimed period of time. As detailed above and below, “the fluid-conducting channel is arranged and configured with an inner diameter of less than 5 mm to retain the liquid in the collection region and to dispense the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior.” is obvious in view of Greter as disclosed in paragraph 38 as cited by Applicant.
With regards to Applicant’s argument that the NPL citations provided to aid in Applicant’s understanding of pressure differences in fluid do not teach a diameter of less than 5 mm (Remarks p. 7), Examiner notes that such was not asserted and such are not cited in any rejection; thus, this argument is moot.
With regards to Applicant’s argument that paragraph 56 of the specification supports that the claimed device with a diameter of less than 5mm dispenses only with the application of pressure which is opposite/fundamentally different than the cited Greter reference that dispenses immediately when the ampule is broke (Remarks p. 7), Examiner notes that it has not been asserted that the specification lacks support for the claimed device and thus this argument is unclear. Further, paragraph 56 is silent to the argued features and instead discloses that “ [0056] The ampule breaker can comprise a plunger movably arranged in the first housing. This plunger is preferably designed and configured to break open a glass ampule that can be received in the holder by pressure of the glass ampule against a projection. The plunger can move the holder in the direction of the projection in order to break off the head of the glass ampule from the base body of the glass ampule. Furthermore, the plunger is preferably designed and configured to pump a liquid from the glass ampule, which was broken open as described above, out of the outlet of the channel of the housing.”. Finally, the argument that the Greter reference that dispenses immediately when the ampule is broke appears to be irrelevant to the claimed scope as there are no limitations provided that preclude such a function. Instead, claim 1 provides that “the fluid-conducting channel is arranged and configured with an inner diameter of less than 5 mm to retain the liquid in the collection region and to dispense the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior.”.
With regards to Applicant’s argument that the MPEP provides a citation from In re Antonie in regards to a result-effective variable, routine experimentation, and obvious to try being not valid rationales as none of the art suggests anything about retaining liquid and dispensing only when a pressure difference is applied or would suggest adjusting the relative dimensions of the channel (Remarks p. 7-8), Examiner notes that Applicant’s citation of In re Antonie from an unspecified location in the MPEP is take out of context. Indeed, MPEP 2144.05(II)(B) provides the portion cited by Applicant, where such is preceded by “The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection.” and followed by “However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” In summary, the MPEP 2144.05(II)(B) acknowledges and rebuts the findings of In re Antonie in view of KSR. MPEP 2143 provides rationales based upon KSR. With regards to the assertion that none of the art suggests anything about retaining liquid and dispensing only when a pressure difference is applied, Examiner notes that such has been addressed above and below. With regards to the assertion that none of the art would suggest adjusting the relative dimensions of the channel, Examiner notes that adjusting dimensions falls under many of the rationales in MPEP 2143 as well as changes in size/proportion of MPEP 214404(IV)(A) and has been appropriately addressed in the rejections below.
Priority
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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 of this title, 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.
Claim(s) 1-4 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter et al. (US 2011/0273954, hereinafter “Greter”).
As to claims 1-4, 6, and 8, Greter discloses a device (Figs. 1-4 and “negative pressure device”/“vacuum device” of ¶11) capable of producing a bone cement (¶s 1, 9, and 10), the device comprising: - an ampule breaker (3, Fig. 1) having a first housing (3, Fig. 1), wherein the first housing comprises a first interior (interior of 3 as shown in Fig. 1, Fig. 1); - a holder (9 and “Holder” as labeled on the illustration of the lower portion of Fig. 1, i.e. protrusions shown around ampule neck in Fig. 1, Fig. 1, ¶33) arranged in the first housing (Fig. 1) capable of receiving a glass ampule (4, Fig. 1, ¶33); - a breaking element (16, Figs. 1-4, ¶s 37 and 46) which is arranged in the first housing (Fig. 1) and is designed and capable of breaking open a glass ampule (4, Figs. 1-4, ¶s 37 and 46) which can be received in the holder (Fig. 1); - a collection region (see illustration of the lower portion of Fig. 1, Fig. 1) which is arranged in the first housing (Fig. 1) and is designed and capable of receiving a liquid from a broken-open glass ampule (4, Fig. 2); - a cartridge (1, Figs. 1-4) capable of receiving a powder component of a bone cement (2, Figs. 1 and 2, ¶s 9 and 30), wherein the cartridge comprises a second housing (1, Fig. 1) having a second interior (interior of 1 as shown in Fig. 1, Fig. 1); and, - a fluid-conducting channel (8) capable of dispensing a liquid from the collection region into the second interior (Fig. 2, ¶s 38-40), wherein the fluid-conducting channel is arranged with an inner diameter (Fig. 1) capable of retaining the liquid in the collection region (Fig. 2, ¶s 38-40) and dispensing the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior (Figs. 1 and 2, ¶s 38 and 39). As to claim 2, Greter discloses a catchment region (see illustration of the lower portion of Fig. 1, Fig. 1) which is arranged in the first housing (Fig. 1) and is capable of receiving a portion of a glass ampule (4, Figs. 2-4) that is broken off by the action of the breaking element (Figs. 2-4, ¶s 37 and 46). As to claim 3, Greter discloses a screen (see illustration of the lower portion of Fig. 1, Fig. 1, ¶s 9 and 31) which is arranged adjacent to the catchment region (Fig. 1, ¶31) and is capable of retaining fragments from a glass ampule (4, Figs. 2-4) broken open in the device in the ampule breaker (Figs. 2-4, ¶31). As to claim 4, Greter discloses that the fluid-conducting channel is arranged at an angle α of 60° to 90° to the second housing (Fig. 1). As to claim 6, Greter discloses that a glass ampule (4) is fastened or fixable in a force-fitting, form-fitting or integrally bonded manner in the holder (Fig. 1). As to claim 8, Greter discloses that the cartridge further contains a powder component (¶9) capable of preparing a bone cement (¶9), wherein the powder component is arranged in the second interior of the second housing (Fig. 1, ¶s 9 and 30).
Greter is silent to the dimension of the inner diameter, i.e. the inner diameter being less than 5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the fluid-conducting channel of Greter to be less than 3 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of Greter would not operate differently with the claimed the inner diameter of the fluid-conducting channel as less than 3 mm and, as the disclosed channel is shown to be a small diameter channel for flow of a liquid bone cement component, such would function appropriately with the claimed values. Further, Greter specifically discloses that the channel functions to receive some of the liquid component prior to activation of a negative pressure device by means of the different height of the liquid and gas expansion pressure (Greter ¶38) and to deliver the rest of the liquid component upon activation of the negative pressure device (Greter ¶39).
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As to claim 7, the combination of Greter discloses the invention of claim 6 as well as that the glass ampule comprises an ampule neck (Fig. 1) having an annular predetermined breaking point (Fig. 1) having an inner diameter (Fig. 1).
The combination of Greter is silent to the dimension of the inner diameter, i.e. the inner diameter of the predetermined breaking point is 4 to 7 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the predetermined breaking point of the ampule neck of the combination of Greter to have be 4 to 7 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of the combination of Greter would not operate differently with the claimed inner diameter of the predetermined breaking point of the ampule neck of 4 to 7 mm and, as disclosed the ampule is shown to have a neck of smaller diameter that breaks when the breaking element is activated, such would function appropriately with the claimed values. Further, the combination of Greter specifically discloses that the predetermined breaking point functions by being severed by activation of the breaking element (¶37) and permitting some of the liquid to flow out of the ampule prior to prior to activation of a negative pressure device by means of the different height of the liquid and gas expansion pressure (¶38).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter in view of Long (US 2002/0003146).
As to claim 9, the combination of Greter discloses the invention of claim 1.
The combination of Greter is silent to the ampule breaker is designed and configured for simultaneously breaking open and dispensing liquid from two glass ampules to the cartridge.
Long teaches a similar device (Fig. 1-14) capable of producing a bone cement (abstract), the device comprising: - an ampule breaker (3s) having a first housing (3s, Figs. 1-2), wherein the first housing comprises a first interior (Figs. 1-2); - a holder (portion defining aperture 10 as shown in Figs. 1 and 2, Figs. 1 and 2) arranged in the first housing (Figs. 1 and 2) capable of receiving a glass ampule (4s); - a breaking element (16, 17) designed and capable of breaking open a glass ampule which can be received in the holder (Fig. 1, ¶26); - a collection region (opening within 18 as shown in Fig. 1, Fig. 1) designed and capable of receiving a liquid (¶25) from a broken-open glass ampule (4, Fig. 1, ¶27); wherein the ampule breaker is designed and capable of simultaneously breaking open and dispensing liquid from two glass ampules to the cartridge (¶26).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the single ampule breaker and corresponding breaking element as disclosed by the combination of Greter to comprise chambers, ampules and corresponding breaking element structures for three ampules as taught by Long in order to provide a known alternative number of ampules (Long ¶24, Greter ¶46).
Claim(s) 1, 10, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jonsson et al. (US 7,073,936, hereinafter “Jonsson”) in view of Greter.
As to claim 1, Jonsson discloses a device (Figs. 1-3) capable of producing a bone cement (abstract), the device comprising: - an ampule breaker (9, Figs. 1-3) having a first housing (9, Figs. 2 and 3), wherein the first housing comprises a first interior (9e, Fig. 1); - a breaking element (13, 18, Figs. 1-3, ¶s 37 and 46) which is arranged in the first housing (Figs. 1-3) and is designed and capable of breaking open a glass ampule (11, Figs. 1-3, col. 4 lines 34-36); - a collection region (below 14 in 9 as shown in Fig. 1, Fig. 1) which is arranged in the first housing (Fig. 1) and is designed and capable of receiving a liquid from a broken-open glass ampule (11, A, Fig. 2, col. 4 lines 34-39); - a cartridge (2, 10, Figs. 1-3) capable of receiving a powder component of a bone cement (B, Figs. 1-3, col. 5 lines 2-3 and 23-30), wherein the cartridge comprises a second housing (10, Fig. 1) having a second interior (interior of 10 as shown in Fig. 1, Fig. 1); and, - a fluid-conducting channel (9c) capable of dispensing a liquid from the collection region into the second interior (Fig. 2, col. 4 lines 34-39), wherein the fluid-conducting channel is arranged with an inner diameter (Fig. 1) capable of retaining the liquid in the collection region (Fig. 2, col. 4 lines 34-39) and dispensing the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior (Figs. 2 and 3, col. 4 lines 34-39). As to claim 10, Jonsson discloses that the breaking element comprises a plunger (18) arranged movably in the first housing (Figs. 1-3, col. 4 lines 18-21) and a projection (13), wherein the plunger is designed and capable of breaking open the glass ampule by applying pressure to push the glass ampule against the projection (col. 4 lines 34-39) and thereby pump the liquid from the glass ampule through the channel, out of the first housing, and into the second housing (Fig. 2, col. 4 lines 34-39). As to claim 11, Jonsson discloses that the ampule breaker further comprises a valve (18d) which is capable of allowing air to flow into the first housing from the outside (col. 4 lines 55-59) in order to pump the liquid from the broken glass ampule through the channel and into the second housing by pressure of the plunger (Figs. 1-2, col. 4 lines 18-40). As to claim 13, Jonsson discloses that the ampule breaker is designed and capable of pumping all of the liquid from the glass ampule through the channel and into the second housing with a single stroke of the plunger (due to the vacuum, Figs. 1-3, col. 4 lines 32-39).
Jonsson is silent to a holder arranged in the first housing configured for receiving a glass ampule as well as the dimension of the inner diameter, i.e. the inner diameter being less than 5 mm.
Greter teaches a similar device (Figs. 1-4 and “negative pressure device”/“vacuum device” of ¶11) capable of producing a bone cement (¶s 1, 9, and 10), the device comprising: - an ampule breaker (3, Fig. 1) having a first housing (3, Fig. 1), wherein the first housing comprises a first interior (interior of 3 as shown in Fig. 1, Fig. 1); - a holder (9 and “Holder” as labeled on the illustration of the lower portion of Fig. 1, i.e. protrusions shown around ampule neck in Fig. 1, Fig. 1, ¶33) arranged in the first housing (Fig. 1) capable of receiving a glass ampule (4, Fig. 1, ¶33); - a breaking element (16, Figs. 1-4, ¶s 37 and 46) which is arranged in the first housing (Fig. 1) and is designed and capable of breaking open a glass ampule (4, Figs. 1-4, ¶s 37 and 46) which can be received in the holder (Fig. 1); - a collection region (see illustration of the lower portion of Fig. 1, Fig. 1) which is arranged in the first housing (Fig. 1) and is designed and capable of receiving a liquid from a broken-open glass ampule (4, Fig. 2); - a cartridge (1, Figs. 1-4) capable of receiving a powder component of a bone cement (2, Figs. 1 and 2, ¶s 9 and 30), wherein the cartridge comprises a second housing (1, Fig. 1) having a second interior (interior of 1 as shown in Fig. 1, Fig. 1); and, - a fluid-conducting channel (8) capable of dispensing a liquid from the collection region into the second interior (Fig. 2, ¶s 38-40), wherein the fluid-conducting channel is arranged and capable of retaining the liquid in the collection region (Fig. 2, ¶s 38-40) and dispensing the liquid to the second interior only when a pressure difference is applied between the collection region and the second interior (Figs. 1 and 2, ¶s 38 and 39).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device as disclosed by Jonsson with by adding a holder as taught by Greter in order to hold and store the ampule within the first housing (Greter ¶33) and act as a seal between the ampule and the first chamber (Greter ¶34). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the inner diameter of the fluid-conducting channel of Jonsson to be less than 3 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of Jonsson would not operate differently with the claimed the inner diameter of the fluid-conducting channel as less than 3 mm and, as the disclosed channel is shown to be a small diameter channel for flow of a liquid bone cement component, such would function appropriately with the claimed values. Further, Jonsson specifically discloses that to permit feeding of the bone cement components/liquid from the collection region of the ampule breaker, the cartridge is required to be connected to an active vacuum source (col. 5 lines 49-53).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jonsson and Greter in view of Sasaki (US 2019/0038330).
As to claim 12, the combination of Jonsson and Greter discloses the invention of claim 11 as well as the valve is a one-way valve (col. 4 lines 57-59 discloses sealing and preventing gases from escaping).
The combination of Jonsson and Greter is silent to the valve comprising a ball valve.
Sasaki teaches a similar device (Figs. 1-16) capable of producing a bone cement (¶1), the device comprising: - a first housing (60), wherein the first housing comprises a first interior (72, i.e. shown holding liquid in Fig. 2, Figs. 2 and 9, ¶41); - a collection region (lower portion of 72 as shown in Fig. 2, Fig. 2) which is arranged in the first housing (Fig. 9) and is designed and capable of receiving a liquid (Fig. 2, ¶s 52 and 53); - a cartridge (12, Fig. 1) capable of receiving a powder component of a bone cement (¶s 52 and 53), wherein the cartridge comprises a second housing (12, Figs. 2 and 9) having a second interior (32); the first housing comprises a plunger (96, Figs. 1, 2, and 9) arranged movably in the first housing (Figs. 1, 2, and 9, ¶s 47 and 50), wherein the plunger is designed and capable of applying pressure to pump the liquid out of the first housing (Figs. 1-5, 9, 10, and 13-16, ¶s 54-57); wherein the plunger is further comprises a valve (112, Figs. 9, 10, and 13-16, ¶s 54-57) which is capable of allowing air to flow into the first housing from the outside (Figs. 9 and 15, ¶50) in order to pump the liquid by pressure of the plunger (Figs. 1-5, 9, 10, and 13-16, ¶s 54-57), wherein the valve is a one-way valve comprising a ball valve (Figs. 13-16, ¶s 49 and 50).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the valve as disclosed by the combination of Jonsson and Greter to be a ball valve as taught by Sasaki in order to selectively allow air flow (Sasaki ¶49) to permit air to be sucked in while sealing and preventing the gases from the liquid bone cement component from escaping into the atmosphere (Jonsson col. 4 lines 55-59).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter in view of Greter (US 9,131,930, hereinafter “Greter’930”).
As to claim 14, the combination of Greter discloses the invention of claim 1 but is silent to the breaking element comprises a button which can be pushed into the first housing from the outside in order to break open a glass ampule, wherein the button is configured to automatically return to its original position after the button has been pushed in.
Greter’930 teaches a similar device (Figs. 26-33) comprising: - an ampule breaker (810) having a first housing (811), wherein the first housing comprises a first interior (812, Figs. 26 and 28); - a breaking element (820, 821, Figs. 26, 28, and 29) which is arranged in the first housing (when actuated, col. 13 lines 47-49) and is designed and capable of breaking open a glass ampule (700, col. 13 lines 47-49); - a collection region (portion of 810 shown just below 710 in Fig. 28, Fig. 28) which is arranged in the first housing (as defined, Fig. 28) and is designed and capable of receiving a liquid from a broken-open glass ampule (700, col. 13 lines 56-58); wherein the breaking element comprises a button (820) which can be pushed into the first housing from the outside (when actuated, col. 13 lines 47-49) in order to break open a glass ampule (when actuated, col. 13 lines 47-49), wherein the button is capable of automatically returning to its original position after the button has been pushed in (col. 6 lines 37-41).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the breaking element as disclosed by the combination of Greter the breaking element as taught by Greter’930 in order to predictably open the ampule (Greter’930 col. 13 lines 46-49) and effect a latching connection (Greter’930 col. 6 lines 37-41), i.e. in order to provide different opening mechanisms for opening an ampule (Greter ¶46).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter in view of Vogt et al. (US 2012/0006874, hereinafter “Vogt”).
As to claim 15, the combination of Greter discloses the invention of claim 1 but is silent to the first housing of the ampule breaker is at least partially flexible in order to break open a glass ampule by bending the first housing.
Vogt teaches a similar device (Figs.1-4) comprising: - an ampule breaker (Figs. 1-3) having a first housing (17), wherein the first housing comprises a first interior (interior of 17 as shown in Figs. 1-3, Figs. 1-3); - a breaking element (19, Figs. 1-3) which is arranged in the first housing (Figs. 1-3) and is designed and capable of breaking open a glass ampule (700, col. 13 lines 47-49); - a collection region (13, Figs. 1-3) which is arranged in the first housing (as defined, Figs. 1-3) and is designed and capable of receiving a liquid from a broken-open glass ampule (Figs. 1-3); wherein the first housing of the ampule breaker is at least partially flexible (Figs. 1-3, ¶51) in order to break open a glass ampule by bending the first housing (Figs. 1-3, ¶48).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the breaking element as disclosed by the combination of Greter the breaking element as taught by Vogt in order to predictably open the ampule (Vogt ¶48), i.e. in order to provide different opening mechanisms for opening an ampule (Greter ¶46).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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