DETAILED ACTION
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 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 Objections
Claim 1 is objected to because of the following informalities: all recitations of the term “the engagement structure” in the claim (see lines 6, 8, 18, 20) should be amended to “the engaging structure”. Appropriate correction is required.
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.
The following claim limitations
Attraction element (claim 1)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Element (Attraction element - claim 1)
coupled with functional language
at least one of the side portions to cause attraction between the side portions to maintain the side portions in the operational positions of the side portions (Attraction element - claim 1)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
magnet (see page 12 of the specification) (Attraction element - claim 1)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 5, 10, 11-13 and 19 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 claim 5:
The claim recites the limitation "the side panel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the heating element" in line 5. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the at least one side portion" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10:
The claim recites the limitation "the heating element" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11:
The claim limitation “a medical implement” in line 1 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a medical implement” in line 2 of claim 1 (on which this claim depends) which raises a question of if two medical implements are required by the claim 11 or only one. For the sake of examination, the office has assumed that only one medical implement is required by the claim.
The claim is also unclear because of the limitation “The system of claim 1 additionally comprising a medical implement” in lines 1-2. The limitation is unclear because the way the structure of the medical implement is claimed suggests it is a required structure of the claims however the way the medical implement is claim in line 2 of claim 1 suggests that the medical implement is beyond the scope of the claim and not required structure. For the sake of examination, the office has assumed the medical implement is required structure of claim 11 however the applicant should amend the claims to clarify.
Claims 12-13 are rejected due to their dependence on claim 11.
Regarding claim 12:
The claim recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Also, the structure of “the medical implement” in line 1 is unclear for the same reasons identified in the claim 11 rejection above. The office has taken the same interpretation.
Claim 13 is rejected due to its dependence on claim 12.
Regarding claim 13:
Also, the structure of “the medical implement” in line 1 is unclear for the same reasons identified in the claim 11 rejection above. The office has taken the same interpretation.
Regarding claim 19:
The claim limitation “a cavity” in line 2 of the claim is unclear. The structure of the cavity overlaps with the structure of the pocket claimed in line 7 of claim 1 (on which this claim depends) raising a question of if they are the same structure or separate structures. For the sake of examination, the office has assumed that the cavity and pocket are one and the same structure. However, the applicant should amend the claim to clarify.
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 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 9621485 A1 to Gilchrist et al. (Gilchrist).
Gilchrist discloses:
Regarding claim 1:
A system (figures 2 and 3) comprising:
an apparatus (1) for warming at least a portion of a medical implement (11), the apparatus comprising:
a medical implement engaging structure (29/12/13 and 30/13/32) for engaging the portion of the medical implement (11) to permit transfer of heat to the implement (the plates 12 and 13 of 29 and 30 supply heat to 11; page 6, lines 31-36), the engagement structure (29 and 30) being configured to form a pocket (see the pocket within 29 and 30 that receives 11) for receiving the medical implement (11), the engagement structure (29 and 30) having a receiving condition (condition as shown in figure 2 where the engage structure 29/30 is opened) and an operational condition (condition where 29/30 is closed and latched into place by spring clips 9), the receiving condition being characterized by the pocket being substantially open (as shown in figure 2 where 29 and 30 are open), the operational condition being characterized by the pocket being substantially closed (where 29 and 30 are closed and heating is applied to 11), the implement engaging structure (29 and 30) comprising:
a pair of side portions (29 and 30) configured to form the pocket (gap formed between 29and 30to hold and heat 11), the side portions (29 and 30) being movable with respect to each other (29 and 30 can be opened relative to each other via hinge 26), the side portions (29 and 30) each having a receiving position corresponding to the receiving condition of the engagement structure (29 and 30) (when 29 and 30 are in the open position as shown in figure 2), the side portions (29 and 30) each having an operational position corresponding to the operational condition of the engagement structure (29 and 30) (when 29 and 30 are in the closed position in order to heat 11), the receiving position of the side portions (29 and 30) being characterized by the side portions (29 and 30) being separated and moved away from each other (as shown in figure 2), the operational position of the side portions (29 and 30) being characterized by the side portions (29 and 30) being moved toward each other and at least partially in contact with each other (where 29 and 30 is closed and 29 and 30 contact each other and the spring latch 9 holds the two closed);
a heat source (12 and 13) configured to warm a said medical implement (11) positioned between the side portions (29 and 30) in the pocket of the engaging structure (29 and 30) (plates 12 and 13 apply heat to the engagement structure 11); and
an attraction element (16/17 as shown in figure 3 or the spring clips 9 as shown in figure 2) on at least one of the side portions (29 and 30) to cause attraction between the side portions (29 and 30) to maintain the side portions (29 and 30) in the operational positions of the side portions (29 and 30) (16/17 or 9 applies a force (attraction forces) to the plates 12/31 and 13/21).
Regarding claim 2:
The system of claim 1 wherein each of the side portions (29 and 30) comprises a side panel (see the side panel of cover 29 or 30), at least one of the side panels being formed of a flexible material (rubber material 31 and 32; page 7, lines 8-11) such that the at least one side panel flexes to form the pocket (the flexing of the material 31/32 changes the position of plates 12 and 13 which forms the pocket to receive 11) in the operational condition (in the closed position of 29 and 30) of the implement engaging structure (29 and 30).
Regarding claim 3:
The system of claim 2 wherein each of the side panels is formed of the flexible material (see the flexible rubber material of 31 and 32; page 7, lines 8-11).
Regarding claim 4:
The system of claim 2 wherein the side panels (29/30) are substantially coextensive with each other in the operational position (coextensive or next to each other when they are in the closed position).
Regarding claim 5:
The system of claim 2 wherein each of the side panels has a perimeter (see the perimeter A in figure 1 below), each of the side panels having a perimeter section (see the perimeter section C in figure 1 below) extending along at least a portion of the perimeter, the side panel further having a central section (see the central section B in figure 1 below) surrounded at least in part by the perimeter section (as shown in figure 1 below), the heating element (12/13) of the side panel of the at least one side portion (see the side portion of 12 and 13 as shown in figure 1 below) being located on the central section of the side panel (as shown in figure 1 below).
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665
1064
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Figure 1 – figure 2 of Gilchrist, annotated by the examiner
Regarding claim 6:
The system of claim 2 wherein the attraction element (16/17 or 9) comprises a plurality of attraction elements (see the plurality of springs/pins 16/17 as shown in figure 3 and plurality of clips 9), at least one of the attraction elements being mounted on each of the side panels (as shown in figure 2 and 3).
Regarding claim 7:
The system of claim 6 wherein the attraction elements (9) are located toward perimeters of each of the side panels (see the spring clips 9 as show in figure 1 above).
Regarding claim 10:
The system of claim 1 wherein the apparatus additionally comprises operational controls (see the controller 28 or 8) for controlling operation of the heating element of the apparatus (column 7, lines 8-15).
Regarding claim 11:
The system of claim 1 additionally comprising a medical implement (11) removably positioned in the pocket (11 is disposable or removable from the pocket of 29/30; page 7, lines 4-8; column 9, lines 4-9) of the medical implement engaging structure (29/12/13 and 30/13/32) between the side portions (29 and 30 as shown in figure 2) of the engaging structure (29 and 30).
Regarding claim 12:
The system of claim 11 wherein the medical implement (11) includes a tubular conduit (see the pipes of 11 as indicated on page 7, lines 17-29) configured to be inserted into an orifice of a body of the patient (the conduit of 11 leads to an orifice of the body since the fluid flowing through 11 is for blood transfusion; page 9, lines 33-34).
Regarding claim 13:
The system of claim 12 wherein the medical implement (11) includes packaging defining an interior, the tubular conduit being positioned in the interior of the packaging (page 9, lines 33-34).
Regarding claim 14:
The system of claim 1 wherein the heat source (12/31 and 13/32) comprises a heating element (see the elements/plates 12 or 13) on at least one side portion of the medical implement (11) engaging structure (29 and 30).
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 9621485 A1 to Gilchrist et al. (Gilchrist) as applied to claim 6 above, and further in view of US 20130174842 A1 to Young et al. (Young).
Regarding claim 8:
Gilchrist fails to disclose:
The system of claim 6 wherein each of the attraction elements comprises a magnet.
Young teaches:
A system (figure 1b) that includes a pair of side portions (62 and 64). Further, the system can include different kinds of latches including fasteners, magnets, clips, button, snap, lock, hook, hook/loop system (e.g., Velcro), press fit, and the like (¶0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilchrist to replace the attraction elements with magnets as taught by Young. This is a simple substitution of one known element (spring latch 9 of Gilchrist) for another (magnet as a latch as taught by Young) to obtain predictable results (told hold the side portions closed).
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 9621485 A1 to Gilchrist et al. (Gilchrist) as applied to claims 1 or 14 above, and further in view of US 5013889 A to Bakke.
Regarding claim 9:
Gilchrist fails to disclose:
The system of claim 1 wherein the apparatus additionally comprises a base structure for supporting the medical implement engaging structure on a surface, the base structure including a power supply.
Young teaches:
A system that includes a blood heater (medical implement engaging structure) (52) that is supported on a base structure (14/15). The base structure includes a power supply (supply’s power to the heater as indicated in column 4, lines 23-46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilchrist to further include a base structure with the power supply to support the medical implement engaging structure as taught by Young since the base structure offers greater stability to the system (Young; column 3, lines 49-56).
Regarding claim 15:
Gilchrist fails to disclose:
The system of claim 14 wherein the heating element comprises an electrical resistance element.
Young teaches:
A system that includes a blood heater (medical implement engaging structure) (52) that is supported on a base structure (14/15). The base structure includes a power supply (supply’s power to the heater as indicated in column 4, lines 23-46). Further, the reference teaches the heating plates can be electrical resistance heaters (column 1, lines 54-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilchrist to replace the heating elements in Gilchrist with electrical resistance heaters as taught by Young. This is a simple substitution of one known element (heating elements in Gilchrist) for another (electrical resistance heaters as taught by Young) to obtain predictable results (to heat 11 and the blood for a transfusion).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 9621485 A1 to Gilchrist et al. (Gilchrist) as applied to claims 1 above, and further in view of US 5807332 A to Augustine et al. (Augustine).
Regarding claim 16:
Gilchrist fails to disclose:
The system of claim 1 wherein the heat source comprises an air heating assembly configured to provide heated air to heat a said medical implement in the medical implement engaging structure.
Augustine teaches:
A system (figure 1 and 2) that includes a heat source (18) that supplies heated air (column 5, lines 30-50) to a pocket/cavity (23 in figure 2). Further, the pocket/cavity includes a medical implement (28) and the pocket is part of a medical implement engaging structure (20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilchrist to replace the heating plates in Gilchrist with a heat source (air generator) with a air pipe supplied to the cavity/pocket as taught by Augustine. This is a simple substitution of one known element (heating plate in Gilchrist) for another (air generator and air pipe supplying heat to the pocket/cavity) to obtain predictable results (to heat the medical implement 11).
Regarding claim 17:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 16 by Gilchrist and Augustine:
The system of claim 16 wherein the air heating assembly includes a heated air generator (see the air generator of Augustine incorporated into Gilchrist) configured to generate heated air for the medical implement engaging structure.
Regarding claim 18:
Gilchrist discloses:
The system of claim 17 wherein the air heating assembly is configured to deliver heated air to the pocket of the medical implement engaging structure (see the pipe and air heater supply heat to the pocket as taught by Augustine and incorporated into Gilchrist).
Regarding claim 19:
Gilchrist discloses:
The system of claim 17 wherein the air heating assembly is configured to deliver heated air to a cavity formed in at least one side portion of the medical implement engaging structure (see the pipe and air heater supply heat to the pocket as taught by Augustine and incorporated into Gilchrist which supply heat to the medical implement engaging structure).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20140128845-A1
Hyun
See the heater 50a
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783