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 . 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.
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.
Claims 13-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 13-28, the claims purport to be directed to “a vapor delivery system” but recite no details whatsoever regarding such a “vapor delivery system.” The claims do not recite any structure that would cause a vapor to be generated; the claims do not even recite what the generator generates or a hypothetical manner in which vapor could be generated/delivered. The claims are entirely directed to a syringe assembly which has infinite uses other than “vapory delivery.” Because it is unclear what structure the claims require with the phrase “vapor delivery system,” the claims are indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-12 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Freund (US 2008/0146917).
Regarding claims 9-12, Freund discloses a syringe assembly (fig. 1) comprising a barrel (100) and an offset exit port (112) including a luer fitting (142) and a plunger (162) removably attached (at any position of the plunger) to a rod (164, [0061]). Delivering fluid by moving the plunger toward the exit port, or filling the syringe with fluid by moving the plunger away from the port, is part of what a person of ordinary skill in the art would understand to by “syringe” (but see also [0061]).
Claims 13-15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Bodduluri (US 2008/0167674).
Regarding claims 13-15, the claims are directed to “a vapor delivery system” with unclear structural features including at least a black box (“generator”) that is usable with some hypothetical syringe assembly having at least the features recited in claim 9. Bodduluri discloses a generator with a cradle (68, fig. 3) for holding a syringe and linear motor for actuating the syringe (62). This can be considered part of a “vapor delivery system” because, for example, vapor can be stored in the syringe. The cradle is capable of being used with a syringe having any conceivable features, including those recited in claim 9, as long as the syringe is sized to fit in the cradle and interact with the linear motor.
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, 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 9-13, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over McClurken (US 2001/0032002) in view of Gorman (US 4,820,306), Bodduluri and Brown (US 2015/0320443).
Regarding claims 9-13, 17, 20 and 21, McClurken discloses a vapor generation system (fig. 1, [0039]) including a generator unit (14) that includes a fluid delivery element (3) that McClurken notes could involve syringes but ultimately is not critical to the invention ([0046]). This clearly indicates that the level of ordinary skill in the art (and presumably most of the medical arts) includes various fluid delivery elements including syringes, and that the particular fluid delivery element is a matter for such a person to choose based on countless reasons including mere preference. Further, it has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Gorman discloses a type of syringe that includes a barrel (11, fig. 1) with a luer fitting coupled to an exit port (15) and a plunger (13) removably attached to a rod (19). This syringe can be filled or emptied by movement of the plunger. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of McClurken to include any commonly known fluid delivery element, including a syringe with the features such as taught by Gorman, that would produce the predictable result of allowing fluid to be provided to an electrosurgical device for vapor generation. While it could be argued that the parts of a generator do not roll around loose within the generator and thus are held by a “cradle,” in the interest of compact prosecution Bodduluri, for example, discloses a system which uses a syringe where the barrel of the syringe is held by a cradle (68, fig. 3). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of McClurken to include a cradle for the syringe as taught by Bodduluri, so that syringe does not flop around inside the generator. It is noted that this clip-style cradle has a degree of flexibility (“snap-fit clamp” [0085]) which constitutes the ability to move laterally within the generator. Gorman does not disclose that the exit port is offset from a center line of the barrel. However, exit ports of syringes are common in the art and there is no evidence that the infinite locations defined by “offset from a centerline” produce an unexpected result (within the meaning of MPEP 716.02(a)). Brown discloses a syringe and teaches that the exit port can be located along the centerline or not ([0024]) which is understood to be a teaching of functional equivalence (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of McClurken to include the exit port on the syringe anywhere exit ports are known to be located, including offset from a centerline as taught by Brown, that would produce the predictable result of allowing fluid to enter/exit the syringe.
Claims 14, 15, 18, 22-24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over McClurken, Gorman, Bodduluri, and Brown, further in view of Scales (US 4,405,249).
Regarding claims 14 and 18, McClurken, leaving the details of the pump to the person of ordinary skill in the art, does not disclose the use of a piston to engage the plunger. However, the prior art discloses countless ways to actuate a syringe, including a piston against a plunger. Scales, for example, discloses a syringe (32, fig. 1) that is operated by actuating a piston (16) to engage a plunger (40). It has been held that the combination of known elements according to known methods to yield predictable results, as well as the simple substitution of one known element for another (MPEP 2141(III)), are obvious modifications, where in this case the “known element” is simply the mechanism used to move a plunger: a rod or a piston. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of McClurken to include a piston for moving the plunger as taught by Scales, that would produce the predictable result of moving the plunger. It is noted that this modification does not prevent such a piston from interacting with the rod.
Regarding claim 15, McClurken, leaving the details of the pump to the person of ordinary skill in the art, does not disclose the use of a linear motor for moving the plunger (which would control the rate fluid is delivered from the exit port). However, linear motors are common in the art and there is no evidence that using a linear motor to move a plunger produces an unexpected result, and it has been held that automatic a manual process (e.g. pushing fluid out of a syringe) is an obvious modification (MPEP 2144.04(III)). Bodduluri discloses that a linear motor (62, fig. 3) is used to operate the syringe. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of McClurken to use any commonly known element for actuating the plunger/piston of the syringe, including a linear motor as taught by Bodduluri, that would produce the predictable result of an operational syringe.
Regarding claims 22-24 and 26-28, the modifications to McClurken as discussed above with respect to one or more of claims 9-17, 17, 18, 20 and 21 include all claimed features. Claims 22-24 and 26-28 do include some different, broader functional language which will be discussed. Regarding claim 22, if the piston did not engage/disengage the plunger, the plunger would not be able to be moved thus the system would be inoperable both in the sense that fluid could not be delivered from the syringe, and in the sense that the syringe could not be replaced. A person of ordinary skill in the art would not build an inoperable system, thus the modifications as discussed above require that the piston is capable of removable engaging the plunger. It is noted, however, that nothing in the claim language excludes a system that could actuate a plunger by using either a piston directly or indirectly through a rod. Regarding claim 26, the removable rod could be removed before, during or after the barrel is inserted into the cradle. These are not method claims which cover the steps of operating an apparatus, these are apparatus claims which cover the structure of the apparatus. Regarding claim 27, the luer fitting, and in fact any conceivable fitting, is configured to connect to some hypothetical element that could be called a “tube member.”
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McClurken, Gorman, Bodduluri, and Brown, further in view of Ramstad (US 2008/0119830).
Regarding claims 16 and 19, McClurken does not disclose the use of a contact switch in the cradle for allowing the syringe to be operated. However, it is very common in the art to provide a sensing element, including a contact switch, to ensure that a system has been assembled in a desired manner prior to operation. Ramstad, for example, discloses a medical system with detachable elements and teaches that contact switches are provided to allow the system to be operated safely once properly assembled ([0030]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of McClurken to include a contact switch, such as taught by Ramstad, in the cradle or anywhere else the contact switch would indicate the installation of a syringe, to produce the predictable result of only allowing operation of the system, including operation of the syringe, when the system is correctly assembled.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over McClurken, Gorman, Bodduluri, Brown and Scales, further in view of Ramstad.
Regarding claim 25, McClurken does not disclose the use of a contact switch in the cradle for allowing the syringe to be operated. However, it is very common in the art to provide a sensing element, including a contact switch, to ensure that a system has been assembled in a desired manner prior to operation. Ramstad, for example, discloses a medical system with detachable elements and teaches that contact switches are provided to allow the system to be operated safely once properly assembled ([0030]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of McClurken to include a contact switch, such as taught by Ramstad, in the cradle or anywhere else the contact switch would indicate the installation of a syringe, to produce the predictable result of only allowing operation of the system, including operation of the syringe, when the system is correctly assembled.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Syringes are a ubiquitous, relatively simple, and feature in many systems making the amount of relevant prior art too numerous to list. However, some particularly relevant references will be cited in the interest of compact prosecution. Regarding another system which uses a piston directly contacting a plunger of a syringe, see elements 34 and 36 in figure 1 of US 6,086,594 to Brown, elements 17 and 17b in figure 2, which also shows a cradle for holding a syringe, of US 6,409,722 to Hoey, and elements 112 and 108 in figure 4 of US 2008/0114315 to Voegele. Regarding the operation of syringes manually or automatically, see for example paragraphs [0141] of US 2015/0112195 to Berger, paragraph [0070] of US 2004/0230316 to Cioanta and paragraph [0057] of US 2009/0198242 to Truckai which explicitly notes these options are “known in the art,” more evidence that the creation and operation of syringes are well within the level of ordinary skill in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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, Joseph Stoklosa can be reached at 571-272-1213. 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.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
