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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-4 drawn to a method for using emergency cardiac and electrocardiogram (ECG) electrode placement device, classified in A61B 5/02.
II. Claims 5-10 drawn to an emergency cardiac and electrocardiogram (ECG) electrode placement device, classified in A61B 5/282.
Inventions I and II are related as a process of use and product. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different ECG device that does not have/require a cable management module comprising an upper cover, a lower cover, an upper guide piece with a first plurality of channels on a first horizontal plane, and a lower guide piece with a second plurality of channels on a second horizontal plane.
Restriction for examination purposes as indicated is proper because all the
inventions listed in this action are independent or distinct for the reasons given above
and there would be a serious search and/or examination burden if restriction were not
required because one or more of the following reasons apply: the inventions have
acquired a separate status in the art in view of their different classifications and the inventions require a different field of search (e.g., searching different
classes/subclasses or electronic resources, or employing different search strategies or
search queries).
Applicant is advised that the reply to this requirement to be complete must
include (i) an election of an invention to be examined even though the requirement
may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
the elected invention.
The election of an invention may be made with or without traverse. To reserve a
right to petition, the election must be made with traverse. If the reply does not distinctly
and specifically point out supposed errors in the restriction requirement, the election
shall be treated as an election without traverse. Traversal must be presented at the time
of election in order to be considered timely. Failure to timely traverse the requirement
will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
the election, applicant must indicate which of these claims are readable upon the
elected invention.
Should applicant traverse on the ground that the inventions are not patentably
distinct, applicant should submit evidence or identify such evidence now of record
showing the inventions to be obvious variants or clearly admit on the record that this is
the case. In either instance, if the examiner finds one of the inventions unpatentable
over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected
invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim
remaining in the application. A request to correct inventorship under 37 CFR 1.48(a)
must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that
identifies each inventor by his or her legal name and by the processing fee required
under 37 CFR 1.17(i).
Applicant’s election without traverse of Invention II (Claims 5-10) in the phone call on 08/31/2026 is acknowledged.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention I, there being no allowable generic or linking claim. Election was made without traverse in the phone call on 08/31/2026.
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 6 and 9 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.
Claim 6 recites the limitations: "the seventh extension member" in line 1, “the sixth extension member” in line 2, “the first extension member” in line 3, “the second extension member” in line 6, “the third extension member” in line 7, “the fourth extension member” in lines 8-9, and “the fifth extension member” in line 10. There is insufficient antecedent basis for these limitations in the claim.
Claim 9 recites the limitation "a seventh extension member" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this seventh extension member is different from the seventh extension member already cited earlier in the claim, or if they are the same structure. For examination purposes, Examiner will treat both seventh extension member as the same structure on the electrocardiogram (ECG) electrode placement device of claim 5.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sujdak (U.S. Patent No. 6847836 B1), in view of Crosby (U.S. Patent No. 8626260 B2), and further evidenced by Gume (“Elongation at break”).
Regarding independent claim 10, Sujdak discloses an emergency cardiac and electrocardiogram (ECG) electrode placement device (10), the device comprising:
a body (12) comprising a plurality of extension members (14 and 16) (Col. 3,
lines 64-67 & Fig. 1), wherein the body comprises a base layer composed of a flexible
material, an adhesive layer composed of a flexible material, and a backing layer
attached to an adhesive surface of the adhesive layer (Col. 4, lines 14-16; Col. 4, lines
19-25 & Fig. 3);
a plurality of electrodes (32a-b, 34a-b, 30a, and 30b-f) each of the plurality of
electrodes comprising a connection stud (64), a contact pad interface (62) and a contact
pad (60) (Col. 5, lines 2-8 & Fig. 4);
a plurality of cables (combination of wires 50 which terminate into two lead bundles 36 and 38) (Col. 4, lines 48-51); and
an electrode connector (52) connected to each of the plurality of cables (Col. 4,
lines 48-57 & Figs. 2 and 5);
wherein each cable of the plurality of cables is positioned between the base layer
and the adhesive layer, and connected to a corresponding electrode of the plurality of
electrodes and the electrode connector (Col. 4, lines 48-50 & Fig. 4);
wherein each of the plurality of extension members extend outward from a center
of the body for proper placement of the plurality of electrodes on a patient (Col. 4, lines
4-11 & Figs. 1-2).
Although Sujdak discloses the device that can be manufactured in at least five different sizes: infant, small, medium, large, and extra-large (Col. 4, lines 20-22), it does not explicitly disclose wherein each extension member has a width ranging from 1 cm to 10 cm, and a length ranging from 5cm to 20cm, or a length L1 ranging from 7.0 to 14.0 inches.
Crosby, in the same field of endeavor, teaches an extension member (10) constructed of any flexible and stretchy material such as silicon, plastic, rubber, elastic, or other stretchable material known within the art (Col. 8, lines 24-27), and having a non-stretched length range of 8 in (15 cm) to 26 in (66 cm), and a non-stretched width range approximately between one 1 in (2.54 cm) to 4 in (10.16 cm) (Col. 8, lines 35-42).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the extension members of Sujdak to be a rubber material with the non-stretched dimensions taught by Crosby for the purpose of allowing stretching for larger individuals (Crosby, Col. 8, lines 33-35).
While Crosby teaches specific materials and non-stretched dimensions of the extension members, both Sujdak and Crosby are silent on the plurality of extension members extending to a length L2 ranging from 10.0 to 16.5 inches.
Gume, in the same field of endeavor, teaches the elongation at break of different types of rubber materials, wherein a natural rubber would have an elongation at break of >500% (see description under “What is elongation at break and elongation at break?” section). The formula for the elongation at break of a material is shown:
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Hence, if the elongation break of a rubber material is 100% and the initial length is 8 in, for example, then the final length can be calculated to be 16 in.
The elongation break for the rubber material used in the Crosby reference, which correlates to the L1 and L2 length of the extension member, is known to be as claimed, as evidenced by Gume. Thus, the rubber material used inherently meets the claim limitation of the plurality of extension members extending to a length L2 ranging from 10.0 to 16.5 inches.
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 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Patent No. 9986929 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims anticipate the claims of theinstant application. Accordingly, the instant application claims 5-9 arenot patentably distinct from the copending patent claims 1-6. Here,the more specific copending application claims encompass the broader instantapplication claims. Following the rationale in In re Goodman 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993), where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Furthermore, any deficiencies in the claim language can be mitigated by secondary reference Sujdak as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Patent No. 10881313 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims anticipate the claims of theinstant application. Accordingly, the instant application claims 5-9 arenot patentably distinct from the copending patent claims 1-5. Here,the more specific copending application claims encompass the broader instantapplication claims. Following the rationale in In re Goodman 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993), where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Furthermore, any deficiencies in the claim language can be mitigated by secondary reference Sujdak as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Patent No. 12274553 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims anticipate the claims of theinstant application. Accordingly, the instant application claims 5-10 arenot patentably distinct from the copending patent claims 1-9. Here,the more specific copending application claims encompass the broader instantapplication claims. Following the rationale in In re Goodman 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993), where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Furthermore, any deficiencies in the claim language can be mitigated by secondary reference Sujdak as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Patent No. 12251227 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims anticipate the claims of theinstant application. Accordingly, the instant application claims 5-9 arenot patentably distinct from the copending patent claims 1-9. Here,the more specific copending application claims encompass the broader instantapplication claims. Following the rationale in In re Goodman 11 F.3d 1046, 29 USPQ2d2010 (Fed. Cir. 1993), where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Furthermore, any deficiencies in the claim language can be mitigated by secondary reference Sujdak as described above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 5-9 would be allowable if rewritten or amended to overcome the Nonstatutory Double Patenting rejections set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 5-9 the Sujdak (U.S. Patent No. 6847836 B1) and the Crosby (U.S. Patent No. 8626260 B2) references fail to teach the ECG device of independent claim 5 as a whole.
Sujdak teaches an ECG electrode chest pad device (10) comprising a plurality of extension members (14, 16) (Col. 3, lines 64-67 & Fig. 1), a plurality of electrodes (32a-b, 34a-b, 30a, and 30b-f), a plurality of cables (50, 36, 38); and an electrode connector (52) connected to each of the plurality of cables (Col. 4, lines 48-57 & Figs. 2 and 5), wherein each of the plurality of extension members extend outward from a center of the body for proper placement of the plurality of electrodes on a patient (Col. 4, lines 4-11). However, Sujdak does not teach a cable management module comprising an upper cover, a lower cover, an upper guide piece with a first plurality of channels on a first horizontal plane, and a lower guide piece with a second plurality of channels on a second horizontal plane, wherein the lower guide piece is placed over the lower cover, the upper guide piece is placed over the lower guide piece, the upper cover is placed over the upper guide piece.
The Crosby reference teaches an extension member (10) having a non-stretched length range of 8 in (15 cm) to 26 in (66 cm), and a non-stretched width range approximately between one 1 in (2.54 cm) to 4 in (10.16 cm) (Col. 8, lines 35-42). However, Crosby does not teach a cable management module comprising an upper cover, a lower cover, an upper guide piece with a first plurality of channels on a first horizontal plane, and a lower guide piece with a second plurality of channels on a second horizontal plane, wherein the lower guide piece is placed over the lower cover, the upper guide piece is placed over the lower guide piece, the upper cover is placed over the upper guide piece.
Lastly, the Gume reference teaches the elongation at break of different types of rubber materials, but is similarly deficient in teaching the missing structure of the cable management module.
Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claims 5-9.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dominguez (US 20020123679 A1) teaches an ECG Chest Electrode Template with built-in electrodes.
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/A.V.G./Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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