DETAILED ACTION
This is a Non-Final Rejection for Application 19/152,401 filed July 30, 2025. This application is a 371 of PCT/US2024/013590 filed January 30, 2024 which is a continuation-in-part of United States Patent Application No. 18/102,889 filed January 30, 2023. Claims 1-20 are currently pending.
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 Objections
Claim 1 is objected to because of the following informalities: “an unlocked configuration” recited in lines 8-9 appears to be the same unlocked configuration recited in lines 3-4 and should be amended to recite “the unlocked configuration”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “a portion of the locking mechanism release button” recited in line 3 appears to be the same portion recited in lines 1-2 and should be amended to recite “the portion of the locking mechanism release button”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “a plurality of plurality of” recited in line 3 should be amended to recite “a plurality of”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “reward progression” recited in line 4 should be amended to recite “rearward progression”, “grove” recited in line 7 should be amended to recite “groove”, and “a locked configuration” recited in line 8 appears to be the same locked configuration recited in line 3 of claim 1 and should be amended to recite “the locked configuration”. Additionally, for clarity, the claim recitations should be separated by punctuation such that the last section recites “decompression of the spring mechanism causes rearward progression of the arm engagement body such that the arm engagement body prevents lateral flexion of the latching tooth flexible arm, the latching tooth is reversibly engaged within at least one groove between the plurality of teeth of the locking surface, and the cervical collar assumes the locked configuration.” Appropriate correction is required.
Claim 20 is objected to because of the following informalities: for clarity, the claim recitations should be separated by punctuation such that the claim body recites “wherein the cervical collar further comprises a safety lock coupled to the lower support arm; the method further comprising twisting the safety lock to achieve an unsecured configuration prior to depressing the locking mechanism release button”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 12-14 and 18-20 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 12 recites the limitation "the rear support member" in line 4. There is insufficient antecedent basis for this limitation in the claim. A rear support member is not recited in claim 12 or a preceding claim from which claim 12 depends. This rejection may be overcome with language such as “a rear support member”.
Claim 13 recites the limitation "the upper chin support arm padding" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The term used in claim 12 is an upper chin support member padding and limitations drawn thereto should use this term to further limit the feature. This rejection may be overcome by amending the upper chin support arm padding to recite "the upper chin support member padding”.
Claim 18 recites the limitation "the elongated arm" in line 3. There is insufficient antecedent basis for this limitation in the claim. The term used in claim 7 is an elongated section and limitations drawn thereto should use this term to further limit the feature. This rejection may be overcome by amending the elongated arm to recite “the elongated section”.
Claims 14 and 19-20 are rejected for depending from a rejected claim and not curing the deficiencies thereof.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 8-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2024/0225883 (Li).
Regarding claim 1, Li discloses an adjustable cervical collar (The adjusting device 100 is an adjustable cervical collar, Figs. 1-12.) comprising:
a lower support arm having a pair of opposing ends (Cowl casing 30 is a lower support arm which has a pair of opposing ends, Fig. 1.);
a locking mechanism coupled to the lower support arm and having a locked and unlocked configuration (Positioning member 20 and unlocking structure 40 together form a locking mechanism and are coupled to the cowl casing, Figs. 2-4. The positioning member 20 and unlocking structure 40 have a locked and unlocked configuration, [0071].);
a pivotable upper chin support arm having opposing ends and coupled to the lower support arm at the opposing ends (Mandibular support 101 and connection member 11 form a pivotable upper chin support arm which has opposing ends coupled to the cowl casing at the opposing ends, Fig. 1.);
wherein the lower support arm and the upper chin support arm rotate about a connecting pivot point when the lower support arm locking mechanism is in an unlocked configuration (The cowl casing 30 and the connection member 11 rotate about rotating shaft 12 which is interpreted as the connection pivot point, Fig. 7.); and
the lower support arm locking mechanism constrains the pivoting positioning of the lower support arm relative to the pivotable upper chin support arm in the locked configuration (Positioning member 20 and unlocking structure 40 constrain the pivoting position of the cowl casing 30 and the connection member 11 when locked, [0068]-[0070].).
Regarding claim 2, Li discloses the adjustable cervical collar according to claim 1, wherein the lower support arm locking mechanism comprises:
a toothed sliding height adjustment piece comprising at least one locking surface (The locking member 21 includes ratchet teeth 211, [0052], Fig. 4.),
wherein the locking surface comprises a plurality of teeth (ratchet teeth 211);
an anchored locking tooth component (positioning member 22);
a spring-loaded sliding lock (return spring 42 and pull cord 43);
an elongated section (positioning column 2213); and
a locking mechanism release button (an unlocking button 41).
Regarding claim 3, Li discloses the adjustable cervical collar according to claim 2, wherein the anchored locking tooth component comprises:
a latching tooth flexible arm (reset member 222); and
an engagement tooth at an end of the latching tooth flexible arm (The tongue 221 which includes a tongue tip 2211).
Regarding claim 4, Li discloses the adjustable cervical collar according to claim 3, wherein the spring-loaded sliding lock comprises:
an arm engagement body (pull cord 43); and
a spring mechanism (return spring 42).
Regarding claim 5, Li discloses the adjustable cervical collar according to claim 4, wherein the at least one locking surface comprises a plurality of grooves disposed between the plurality of teeth, each of the grooves comprising a shape that is complementary to that of the engagement tooth such that, when in the locked configuration, at least one of the grooves receives the engagement tooth therein (Positioning grooves 212 area plurality of grooves between the teeth 211 and are complementary to the tongue tip 2211 to engage in a locked configuration, [0052], Fig. 3.).
Regarding claim 8, Li discloses the adjustable cervical collar according to claim 2, wherein the lower support arm comprises: a lower support arm outer shell; and a lower support arm inner shell, the locking mechanism is coupled to the lower support arm inner shell (The cowl casing 30 includes a front half casing 31 and a rear half casing 32, [0093], Fig. 2.).
Regarding claim 9, Li discloses the adjustable cervical collar according to claim 8, wherein at least a portion of the locking mechanism release button extends through a portion of the lower support arm outer shell such that a portion of the locking mechanism release button is accessible (The cowl casing 30 further defines therein an unlocking hole 311 communicating with the accommodation chamber, and the unlocking structure 40 further includes: an unlocking button 41 located in the unlocking hole 311, [0089], Fig. 2.).
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) 10-11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0225883 (Li) in view of US 2018/0078400 (Hsu).
Regarding claim 10, Li discloses the adjustable cervical collar according to claim 2.
Li does not disclose a rear support member attachable from the lower support arm, the rear support member comprising: a rear support member frame component and a pair of upper shoulder members, wherein the rear support member is attachable to the lower support arm via the upper shoulder members.
However, Hsu teaches an analogous neck brace with a rear support member attachable from the lower support arm (Fig 3, rear support 204), the rear support member comprising: a rear support member frame component and a pair of rear support member attachment straps for coupling the rear support member to the lower support arm (Fig 3, frame 204, straps 216).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rear member attachment to the front member of Li to be the strap system as taught by Hsu in order to make donning easier (Hsu et al [0022]).
Regarding claim 11, Li in view of Hsu discloses the adjustable cervical collar according to claim 10 wherein the rear support member frame component comprises: a pair of rear support member attachment strap slots for accepting corresponding rear support member attachment straps (Hsu et al Fig 15C, slots 436).
Li in view of Hsu, as modified above, does not disclose a rear support member lower member; a pair of rear support member upper shoulder members, and a pair of rear support member upper neck members.
However, Hsu further teaches a rear support member lower member (Fig 15A, a lower member 416); a pair of rear support member upper shoulder members (Fig 15A, shoulder members 405), a pair of rear support member upper neck members (Fig 15A, [0013], neck supports 412).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rear support of Li with the neck supports as taught by Hsu in order to improve user comfort (Hsu et al [0130]).
Regarding claim 15, Li discloses the adjustable cervical collar according to claim 2.
Li does not disclose a safety lock coupled to the lower support arm, the cervical collar having a secured and unsecured configuration, the safety lock being configured to permit the cervical collar to toggle between the secured and unsecured configuration, wherein the secured configuration prevents the cervical collar from assuming the unlocked configuration; and the unsecured configuration permits the cervical collar to assume the unlocked configuration.
However, Hsu discloses an analogous cervical collar to the cervical collar of Li which comprises a lock mechanism 282, [0111], Fig. 8. The lock mechanism 282 offers an extra layer of protection to assure the adjustment mechanism 220 cannot be tampered with or inadvertently adjusted during normal use making it a safety lock. The lock mechanism 282 is coupled to the lower support arm (base 242, Fig. 8), the cervical collar having a secured and unsecured configuration, the safety lock being configured to permit the cervical collar to toggle between the secured and unsecured configuration, wherein the secured configuration prevents the cervical collar from assuming the unlocked configuration; and the unsecured configuration permits the cervical collar to assume the unlocked configuration ([0111]).
Therefore, it would have been obvious to modify the cervical collar of Li to include a safety lock as taught by Hsu. Hsu teaches that the safety lock offers an extra layer of protection to assure the adjustment mechanism cannot be tampered with or inadvertently adjusted during normal use ([0111]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0225883 (Li) in view of US 5,010,877 (Druskoczi).
Regarding claim 12, Li discloses the adjustable cervical collar according to claim 1, further comprises: a lower support arm padding coupled to the lower support arm (Fig 1, front pad 102) … a rear support member padding coupled to the rear support member (Fig 1, back pad 103) … and an upper chin support member padding coupled to the upper chin support arm (Fig 29, [0058], chin support with padding).
Li does not disclose a lower support arm padding coupled to the lower support arm using one or more first lower pocket outer item; a rear support member padding coupled to the rear support member using a top pocket outer item and a second lower pocket outer item.
However, Druskoczi teaches an analogous neck orthosis having a lower support arm padding coupled to the lower support arm using one or more first lower pocket outer item (Fig 8, front 34 with lower support arms attached to padding layer 36 via pockets 41/40); a rear support member padding coupled to the rear support member using a top pocket outer item and a second lower pocket outer item (Fig 8, back 35 padding 44 coupled via pockets 44d, 44b);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the padding of Li to be attached via pockets as taught by Druskoczi in order to allow removal and washing (Druskoczi Col. 1, Lns. 35-40).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0225883 (Li) in view of US 5,010,877 (Druskoczi), and further in view of US 6,027,467 (Nakamura et al.).
Regarding claim 13, Li in view of Druskoczi discloses the adjustable cervical collar according to claim 12.
Li in view of Druskoczi does not disclose wherein the upper chin support arm padding, the lower support arm padding, and the rear support member padding each having a laminated outer layer and a plurality of plurality of raised padding sections.
However, Nakamura teaches an analogous neck support with a chin, posterior, and anterior region, the padding of each region having a laminated outer layer and a plurality of plurality of raised padding sections (Fig 1, outer layer 3 and raised sections 31. ).
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 the padding of Li in view of Druskoczi to have the raised sections as taught by Nakamura in order to allow the padding to better curve to surround the neck of the user (Col. 3, Lns. 1-5).
Regarding claim 14, Li in view of Druskoczi and Nakamura discloses the adjustable cervical collar according to claim 13, wherein the plurality of raised padding sections being molded into a single layer (Nakamura discloses all of the padding, outer layer 3 and raised sections 31, is a single layer that is capable of being made by a molding process. The recitation “molded into a single layer” is considered a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I).).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 6, the closest prior art of record is US 2024/0225883 (Li) which does not disclose wherein the spring-loaded sliding lock comprises an anchor prong that is disposed at one end of the spring-loaded sliding lock and the arm engagement body is disposed at an end of the spring-loaded siding lock that is opposite to that of the anchor prong such that the spring mechanism is disposed between the anchor prong and the arm engagement body. This limitation in combination with the limitations of claims 1-5 is not found in the prior art and therefore is indicated as allowable subject matter. Claims 7 and 18-20 also contain allowable subject matter due to their dependence upon claim 6.
Regarding claim 16, the closest prior art of record is US 2024/0225883 (Li) in view of US 2018/0078400 (Hsu), which discloses or makes obvious the limitations of claims 1-2 and 15. However, Li in view of Hsu does not disclose wherein the safety lock comprises a blocking wall and a passthrough; the locking mechanism release button comprises a locking extension, the locking extension being dimensionally smaller than the passthrough such that the locking extension can fit therewith. This limitation in combinations with the limitations of claims 1-2 and 15 is not found in the prior art and therefore is indicated as allowable subject matter. Claim 17 also contain allowable subject matter due to its dependence upon claim 16.
Claims 6-7 and 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 18-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending application contains all of the limitations of claim 1 of the present application and further limitations.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the copending application contains all of the limitations of claim 2 of the present application and further limitations.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of the copending application contains all of the limitations of claim 3 of the present application and further limitations.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of the copending application contains all of the limitations of claim 4 of the present application and further limitations.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of the copending application contains all of the limitations of claim 8 of the present application and further limitations.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of the copending application contains all of the limitations of claim 9 of the present application except that the button extends through the outer shell however, the copending application is accessible from outside the outer shell and it would be obvious for the button to extend through the outer shell to be easier to press.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of the copending application contains all of the limitations of claim 10 of the present application and further limitations.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of the copending application contains all of the limitations of claim 11 of the present application and further limitations.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of the copending application contains all of the limitations of claim 12 of the present application and further limitations.
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 13 of the copending application contains all of the limitations of claim 13 of the present application and further limitations.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/102,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of the copending application contains all of the limitations of claim 14 of the present application and further limitations.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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, Rachael Bredefeld can be reached at (571)270-5237. 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.
/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
Prosecution Insights