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 .
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 15 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. Regarding claim 15, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, 13-17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Naftalovitz US 2020/0330327.
As to claim 1, Naftalovitz teaches a method of filling a syringe 550 with a liquid 600, comprising the steps of:
filling an intermediate volume of a buffer member 100 (Figs. ;paras. 0134-0136, ) with the liquid 600;
drawing the liquid from the intermediate volume of the buffer member 100 into the main volume 572 of the syringe 550 such that the main volume 572 is essentially free of air (para. 0142). Naftalovitz does not specifically teach disconnecting the buffer member 100 from the syringe 550. Naftalovitz does teach the buffer member 100 is connected to a syringe adapter 560, which is connected to a syringe assembly 550 (Fig. 15A). Naftalovitz further teaches the syringe adapter 560 comprises a needle 569 that is inserted into the syringe 550. The needle 569 is removed, which disconnects the syringe adaptor (Fig. 19A; paras. 0168-0170). Naftalovitz discloses the claimed invention except for the parts are separate and have intervening parts, i.e. syringe and vial adaptors. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to integrate the parts, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
As to claim 2, the method according to claim 1, wherein the intermediate volume 106 of the buffer member 100 is filled by drawing the liquid into the intermediate volume using a syringe 550 connected to the buffer member 100 (Figs. 15A, 15B; paras. 0134-0136).
As to claim 3, the method according to claim 1, wherein the liquid 600 is drawn into the intermediate volume 106 through a filter needle 110 (Figs. 15B, paras. 0019-0020, 0134).
As to claim 4, the method according to claim 1, further comprising connecting a non-filter needle 596,560 to the syringe 550 (paras. 0135) after disconnecting the buffer member 100 from the syringe 550 (15A, 16A, 17A, 18A, 19A, 19B; paras. 0134-0135).
As to claim 5, the method according to claim 1, wherein the liquid 600 is a liquid medicament (para. 0131).
As to claim 6, the liquid medicament is filled into the intermediate volume from a glass ampoule or from a vial 500 with a rubber stopper 508 – where Naftalovitz teaches the septum is rubber (Figs. 15A,15B; paras. 0089, 0107).
As to claim 7, the method according to claim 1, wherein using the syringe 550, the liquid 600 is first drawn into the main volume 572 of the syringe, subsequently pushed into the intermediate volume of the buffer member, and then drawn from the intermediate volume of the buffer member back into the main volume of the syringe (paras. 0014-0015, 0018, 0144-0147).
As to claim 8, Naftalovitz does not specifically teach the method according to claim 1, wherein the volume of liquid drawn into the main volume of the syringe is less than 1 mL amounts. However, Naftalovitz does teach a required amount of fluid is retrieved from the vial into the syringe using the closed fluid transfer system (Fig. 18A, 18B para. 0056). One having ordinary skill in the art would be able to determine through routine experimentation, the amount of fluid needed in the syringe for the treatment of certain medical conditions.
As to claim 9, A method of filling a plurality of syringes with a liquid, comprising the steps of:
filling an intermediate volume of a buffer member with the liquid;
connecting one or more syringes 550 to the buffer member 100; and
drawing liquid from the intermediate volume into main volumes of the one or more syringes – see the rejection of claim 1, supra.
As to claim 10, the method according to claim 9, further comprising a step of connecting a filter needle 110 to the buffer member 100, and wherein the liquid is drawn through the filter needle into the intermediate volume 106 (9B; paras 0099-0101, 0131-0133).
As to claim 11, Naftalovitz does not specifically teach the method according to claim 9, wherein the volume of liquid drawn into the main volume of each of the syringes is less between 0.01 to 0.5 ml. However, Naftalovitz does teach a required amount of fluid is retrieved from the vial into the syringe using the closed fluid transfer system (Fig. 18A, 18B para. 0056). One having ordinary skill in the art would be able to determine through routine experimentation, the amount of fluid needed in the syringe for the treatment of certain medical conditions.
As to claim 13, Naftalovitz teaches a kit of parts for forming a syringe assembly 550, the kit of parts comprising: a syringe 550 with a main volume 572 for receiving a liquid 600 (Fig. 15A; paras. 0134-0135);
a buffer member 100, comprising a buffer body defining an intermediate volume 106 for receiving a fluid into,
a fluid inlet 114 into the intermediate volume 106 (Fig. 1; paras. 0062-0063); and
a vent opening 540 for venting air from the intermediate volume (Fig. 9B; paras. Abstract; 0012, 0016-0018, 0096, 0100, 0126);
wherein the buffer member 100 is connectable to the syringe 550 to form the syringe assembly, and, in a connected state, the main volume 572 and the intermediate volume 106 are in fluid communication (Figs. 15A, 15B; paras. 0115, 0130, 0138-0139).
As to claim 14, the kit of parts according to claim 13, wherein:
the syringe 550 comprises an elongated syringe body 570 defining the main volume 572 (Figs. 15A, 15B paras. 0113; 0143-0144) and
a maximum cross-sectional area of the intermediate volume 106 of the buffer body 100 is larger than a maximum cross-sectional area of the main volume 572 of the syringe 550 in a direction perpendicular to an elongation direction of the syringe body 570 (Figs. 15A, 15B).
As to claim 15, Naftalovitz does not specifically teach the kit of parts according to any of the claim 13, wherein the maximum cross-sectional area of the main volume is less than 25 mm², and the maximum cross-sectional area of the intermediate volume is less than 2x10³ mm², for example equal to or less than 1.2x10³ mm². Naftalovitz does teach the general condition of the maximum cross-sectional area of the main volume 572 is less than the maximum cross-sectional area of the intermediate volume 106 (of 100) as seen in Fig. 15B. Therefore, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide the syringe and the buffer with the claimed cross-sectional areas, since where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller et al. 105 USPQ 233.
As to claim 16, the kit of parts according to claim 13, wherein at least part of an inner surface of the buffer body facing the intermediate volume is a hydrophobic surface - where Naftalovitz teaches the vial connector portion 102 is an integral part preferably made of plastic (para. 0067) and the deformable membrane 108 is an integral part, preferably made of plastic high-barrier laminate (para. 0076; Figs. 5A, 5B).
As to claim 17, the kit of parts according to claim 13, wherein an inner surface of the buffer body facing the intermediate volume is essentially free of liquid lubricants – where Naftalovitz teaches an inner surface of the buffer body includes the deformable membrane 108, which is preferably made of plastic high-barrier laminate (para. 0075; Figs. 5A, 5B), thus it is reasonable to assert that the laminate, being a barrier material, would essentially be free of lubricants.
As to claim 19, the kit of parts according to claim 13, wherein when, in use, the fluid inlet 114 and the vent opening 540 are aligned in an approximately horizontal plane – where the vent opening 540 is parallel to the needle 596 (Fig. 15B). As the needle 596 is inserted into the inlet 114, the vent opening 540 is aligned in a horizontal plane with the inlet (Fig. 15B);
the buffer member 100 is arranged for holding a sub-volume of liquid in the intermediate volume 106 below the fluid inlet 114 and the vent opening 540 (Fig. 15A, 15B). As to the volume of liquid 600, Naftalovitz does not specifically teach the sub-volume approximately corresponds to at least 0.2 times the size of the main volume of the syringe. However, Naftalovitz does teach a required amount of fluid is retrieved from the vial into the syringe using the closed fluid transfer system (Fig. 18A, 18B para. 0056). One having ordinary skill in the art would be able to determine through routine experimentation, the amount of fluid needed in the syringe for the treatment of certain medical conditions.
As to claim 20, A buffer member 100 (Fig. 1) for use in the method according to claim 1, comprising:
a buffer body 102,104 defining an intermediate volume 106 for receiving a fluid into;
a fluid inlet 114 into the intermediate volume 106 (Fig. 1; paras. 0062-0063); and
a vent opening 540 (Fig. 9B; paras. 0096, 0100) for venting air from the intermediate volume, wherein the fluid inlet 114 is arranged to be connected to a tip of a syringe (para. 0062).
As to claim 21, the buffer member 100 according to claim 20, wherein at least part on an inner surface of the buffer body 102,104 facing the intermediate volume 106 is a hydrophobic surface – where Naftalovitz teaches the vial connector portion 102 is an integral part, preferably made of plastic (para. 0067) and the deformable membrane 108 is an integral part, preferably made of plastic high-barrier laminate (para. 0076; Figs. 5A, 5B).
As to claim 22, the buffer member according to claim 20, wherein the intermediate volume 106 of the buffer body 102,104 is sterile – where Naftalovitz teaches the buffer attached to a vial and a syringe through a closed fluid transfer system (para. 0132).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Browka et al. USPN 10,314,966 is cited to show systems and methods of infusion of medical fluids.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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