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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/28/2025 has been entered.
All previous claims 1-45 and 46-51 (including non-elected Groups II-III) have been canceled by the applicant’s current claim amendments.
Claims 52-54 (taken herein as elected and examined Group I; directed to “A method for protecting gingival or mucosal tissue from radiomimetic damage during peroxide-based dental bleaching…”) have been newly presented for examination, and have been examined on their merits in this action hereinafter.
NOTE: It is to be noted that in order for compact prosecution of this pro-se application, examiner had already suggested the subject matter and appropriate format for the allowable claims with Advisory action previously sent by the office on 05/12/2025 (see ADV, pages 3-4).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/12/2025, 05/26/2025 and 06/12/2025 have been considered by the examiner and made of record.
All previous objections/rejections have been withdrawn in view of cancellation of all previous claims by the applicant and presentation of new claims 52-54 as currently being examined on record as follows:
Claim Objections - New
1. Claim 52 (as newly recited) is objected to because of the following informalities:
A. claim 52 in line 4 recites the limitations “as a required DNA compaction agent”, which should be amended to simply recite “as a
B. claim 52 in section (b), line 1 recites the limitations “wherein the components provide…”, which should be amended to recite “wherein the formulation provides…”, in order to properly conform to the step (a) of “administering a formulation…”.
C. claim 52 recites an abbreviation in the form of “ALARA principles” in section (e) line 2, which should be recited in full form, at least the first time it appears in a claim (see instant specification dated 02/07/2021, page 34, third paragraph, for instance). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - New
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.
1. Claims 52-54 (as newly presented) 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.
A. Regarding claim 52, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 52 in section (b) recites the limitations “wherein the components provide protective effects across multiple protective mechanisms such as DNA compaction and antioxidation…”, wherein the term “such as” (taken as an exemplary limitation) renders the claimed process ambiguous and confusing because it is unclear if the limitations recited after that term are actually required, or they are only exemplary in nature.
Similar situation arises in claim 54 which recites (in lines 1-2) the limitations “wherein the dosage amounts also include ‘up to’ amounts such as (a) sea buckthorn oil…”, which renders the claimed process ambiguous and confusing because it is unclear if the limitations recited after that term “such as” are actually required, or they are only exemplary in nature. Appropriate correction is required.
B. Claim 52 recites in section (f), lines 2-3, the limitations “…an said compaction resists DNA single and double strand breaks, and after the danger has passed, the compaction subsides…”, which is ambiguous and confusing. First, the term “the danger” does not have proper antecedent basis in the claim 52 as currently presented. Second, it is unclear as to what danger is being referred to, because no such danger has been recited before section (f). If applicant intends to recite “peroxide-based dental bleaching” procedure (i.e. equating to a danger per se), necessary amendment should be provided. Appropriate correction is required.
C. Claim 52 recites (in lines 4-8, sections (i) to (iv), in particular) the following doses/dose ranges for the method step “(a) administering a formulation comprising”:
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While the use of botanical names in parenthesis after the common name of the plant is acceptable (similar to an abbreviation for a chemical compound name), the recitation of dose level/regimen in parenthesis as presented in claim 52 renders the claimed process indefinite. It is unclear if the doses or amount limitations presented in parentheses are exemplary, or actually required (i.e. limiting) in the claimed process. This raises ambiguity about the scope of the claimed components used in the formulation employed by the process as claimed. Thus, the metes and bounds of the claimed process is not properly defined.
Similar situation arises in instant claim 54 that recites dose range limitations in parentheses as reproduced below:
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The recitation of dose ranges in parentheses renders the claim indefinite, as it is unclear if the limitations of dose/range presented in parenthesis are required by the claimed step, or they are in fact exemplary. Appropriate correction is required.
Additionally, the dose range(s) presented in parentheses raise another level of ambiguity because the limitations “(up to 15 g/day)”, for instance, would normally be understood to encompass a range of from 0 to 15 g/day for the recited component “sea buckthorn oil”, which essentially renders the component optional or not required. Similar situations are pertinent to the currently recited dose ranges for “rose hips oil”, “flaxseed oil”, and “vitamin C”, “vitamin E”, “glutathione (GSH)” and “alpha lipoic acid (ALA)”, as presented in instant claim 54. Thus, the scope of the claimed process is deemed ambiguous and indefinite for the above discussed reasons. Appropriate correction is required.
D. Claim 52 as newly recited requires the method steps (a) through (h) separated via semicolons, without any conjunction (i.e. “and” or “or”) before the last step (h) after the semicolon, and therefore, it is unclear if all of the sections from (a) to (h) are required, or any one of from (a) to (h) sections? (However, in the interest of compact prosecution of this Pro-Se case, instant claim 52 has been interpreted, for the prior art purposes, to require all of the sections from (a) to (h) as currently recited). Appropriate correction is required.
E. Claim 54 recites the limitation "the dosage amounts" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 54 directly depends from independent new claim 52, however, the term “dosage amounts” has not been presented in claim 52, as recited, and therefore claim 54 lacks appropriate basis for limitations “the dosage amounts”.
Additionally, claim 54 recites components (a), (b), (c), each separated by a semicolon, wherein component (c) now has flaxseed oil, vitamin C, vitamin E, glutathione, and alpha-lipoic acid (see recitation of independent claim 52 section (a), subsections (i) to (iv), in particular) . The recitation is ambiguous and confusing because it is unclear as to what exactly is being required by the claimed process. The metes and bounds of the claimed process cannot be properly determined (see also discussion above regarding use of “such as” language in the claim).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d) - New
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
1. Claim 53 (newly presented) is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 53 (directly depends from claim 52) recites the limitation of “wherein the dosage form further includes…suspensions,…”, which is already provided for in the independent claim 52, section (g), and therefore claim 53 fails to further limit the process of claim 52.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Appropriate correction is required.
NOTE: 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 § 103 – New Grounds
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.
1. Claims 52-54 (as newly presented) are rejected under 35 U.S.C. 103 as being unpatentable over Prasad et al (US 2003/0064955 A1; previously made of record) taken with Bar-Or (WO 03/043518 A2; previously made of record), Tamas et al (RU 118629 B1; PTO English translation previously made of record), Bhatia et al (2007; NPL previously made of record) and Abele et al (2002; NPL Summary, previously made of record).
Newly presented claims 52-54 (filed with RCE on 06/28/2025) have been reproduced as follows:
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See also the above discussed claim objections and 112b rejections regarding claim recitations. It is to be noted that the instant disclosure of record does not define and/or exemplify any specific “therapeutically effective amount” for the recited components (or a particular combination thereof) required for administration to a particular subject in need thereof for “synergistic” radioprotection as intended by the claimed process.
Prasad et al (2003), while teaching the use of multiple antioxidant micronutrients as systemic biological radioprotective agents against potential ionizing radiations risks (see title, Abstract, [0006]-[0008], [0038], [0051]-[0052], [0056]-[0057], Table 1 and Table with “Baseline Formulation (SEVAK)” on page 5, for instance), disclose methods of preventing/mitigating or treating the negative oxidative effects of radiation exposure (such as exposures to X-rays during chest X-ray, dental X-ray, etc.; see [0038], for instance) by administering to a subject (such as human) in need thereof, suitable dosage of active anti-oxidants prior to anticipated exposure (see [0032], Table in paragraph [0051], claims 1, 4-6, for instance), wherein the dose levels (for example, formulated as capsule as oral dosage form; see page 5, Table at left column) may be adjusted proportional to the radiation levels likely to be encountered; wherein the basic formulation comprises suitable amounts of vitamin A palmitate, vitamin E, buffered vitamin C (as calcium ascorbate), vitamin B12, along with folic acid and other B vitamins, and mineral salts that include seleno-methionine (salts including calcium citrate, magnesium citrate, zinc glycinate, chromium picolinate, etc.). Prasad et al also disclose the fact that glutathione (see [0055]-[0056], for instance) is considered a very effective antioxidant, and may be substituted with N-acetylcysteine (NAC) and alpha-lipoic acid that are rapidly absorbed and are known to actively increase the intracellular levels of glutathione without causing any toxicity, and in addition have been shown to be of radioprotective value in experimental systems (in vitro as well as in vivo; see [0056], and cited references therein, for instance). Prasad et al also disclose the art-known fact that “…vitamin C and vitamin E are synergistic as antioxidants against free radicals because they are able to protect both the aqueous and lipid environments of the cells respectively” (see [0058], for instance).
However, Prasad et al do not explicitly disclose the use of a formulation comprising antioxidant combinations that include - sea buckthorn (Hippophae rhamnoides) oil, glutathione (GSH), vitamin E, and flaxseed oil; and wherein the subject is expected to be exposed to peroxide-based dental bleaching agent causing negative oxidative effects and inflammation of gingival and/or mucosal tissues, i.e. radiomimetic damage (see newly recited claims 52-54).
Bar-Or (2003), while teaching metal-binding peptide-based oral care compositions and methods of treating mouth tissues (see Title, Abstract, and Summary), disclose the fact that reactive oxygen species (ROS) are produced during exposure to variety of environmental conditions including exposure to radiations, use of oral care products including tooth whitening agents that liberate active oxygen or hydrogen peroxide (i.e. bleaching agents that are linked to production of ROS in affected tissues; see page 2, 2nd paragraph; page 34, last paragraph; page 35, 2nd paragraph, for instance). In order to reduce their negative effects, they disclose methods and compositions that include anti-oxidants and anti-inflammatory agents in order to reduce gingival and/or oral mucosal tissue damage done by ROS (see page 28, last full paragraph, and page 29, 3rd paragraph, for instance) with or without various oral disease conditions, wherein suitable anti-oxidants may include superoxide dismutase (SOD), catalase, glutathione peroxidase, glutathione itself, N-acetyl cysteine, ascorbic acid, alpha-tocopherol, vitamin A, beta-carotene, etc. Thus, Bar-Or teaches the use (prophylactic use before dental procedures included; see page 39, last paragraph, and page 40, 2nd paragraph, for instance) of formulations that may include antioxidants such as glutathione, SOD, and other anti-inflammatory agents in order to treat oral tissues that are either damaged by ROS or to prevent such damage induced by their ROS-based oxidative damage to mouth tissues, in particular as oral care formulations that may include gels, paste, liquids, mouth washes, sprays, gargles, capsules, lozenges, chewable tablets or gums, films, strips, (see disclosure for various types of art-known oral dosage forms on pages 30-35, and 38, for instance).
Tamas et al (2003; per English translation of record), while teaching medical compositions for stomatological use (see title, Abstract and page 2, for instance), disclose formulations in a gel form (for oral/dental care use in patients) that comprise an anti-inflammatory medicinal oil component comprising sea buckthorn oil (see page 2, last paragraph); wherein they disclose that such medicinal oils comprise natural compounds with anti-inflammatory properties that heal and regenerate/restitute altered oral tissues, and can be formulated to comprise from 1.5% to 5.5% of sea buckthorn oil (see page 3, 2nd paragraph, for instance).
Bhatia et al (2007) disclose prophylactic effects of flaxseed oil against radiation-induced toxicity of liver tissue in mice (see Abstract, and Introduction on page 852, for instance), wherein they disclose the art-known fact that natural plant-based antioxidants have been found to provide protection of living tissues against radiation damage (see Introduction, left column on page 852), wherein the oral administration of flaxseed oil to model mice (see section “Materials and Methods” on page 853, section “Determination of optimal dose of flaxseed oil against radiation”, in particular) equivalents to 2, 4, 6, 8 mL/Kg body weight/day provided significant radioprotective effects, especially in terms of its antioxidative potential (see entire Abstract, in particular), wherein the antioxidative protection afforded by flaxseed oil may be attributed to the constituents of the oil, which include omega-3 essential fatty acids and phytoestrogenic lignans, which appear to play an important role in free radical scavenging and singlet oxygen quenching. Thus, Bhatia et al clearly establish the strong anti-oxidant properties of flaxseed oil upon oral administration in animals or subjects in need of protection from ROS and/or oxidative damage induced by radiation.
Therefore, given the detailed teachings and/or suggestions from the cited prior art of Tamas et al, Bhatia et al and Bar-Or as specifically discussed above, to a person of ordinary skill in the art, it would have been obvious to include such antioxidants such as glutathione, or alpha-lipoic acid in combination with vitamins A, E, C, and other B vitamins (disclosed by Prasad et al) and medicinal natural plant-based oils having strong anti-oxidant properties such as sea buckthorn oil and flaxseed oil (see specific disclosure and advantages taught by Tamas et al and Bhatia et al, above), in order to prepare suitable oral formulations (that are adaptable in various dosage forms as already taught by Bar-Or, as discussed above) that can be effective in prevention as well as mitigation/treatment of oral tissues including gingival/mucosal tissue in mouth of subjects in need thereof (such as for patients undergoing dental work including peroxide-based dental bleaching, and/or exams using dental X-rays, or in anticipation thereof) that are anticipating to be exposed with negative effects of free radicals or ROS, as suggested by the combined disclosure from Prasad et al when taken with Bar-Or, Tamas et al, and Bhatia et al, as discussed above.
The additional limitations of claim 52 recited under sections (b), (e) and (f), which are being taken as functional properties and/or intended result of the formulation/components used, would have been obvious to a person of ordinary skill in the art as such results and/or properties were intrinsic to the components and/or amounts/doses used that would variously depend on the type of subject, type of bleaching agent used, degree of tissue damage expected, amounts/dose regimen employed prior to the treatment, specific route of administration, etc., to name a few relevant factors. Moreover, as noted above, claim 52 as presented, does not specify any specific subject in need, and/or specific combination of the components in the formulation used in the process, and therefore since the cited prior art already disclose the benefits and/or significant advantages of combining various known anti-oxidant compounds, vitamins, medicinal oils, etc., that have been known and demonstrated for their anti-oxidant properties that protect against ROS or oxygen-based free radical damage of tissues (especially in mouth gingiva/mucosal tissues), an artisan in the art would have fully contemplate such functional properties and/or intended results as currently recited in claim 52. Since, the cited prior art of Prasad et al already disclose the use of the formulations prior to radiation exposure or tissue damage therefrom, the limitations of claim 52, as presented would have been obvious to an artisan of ordinary skill in the art, unless evidence/data provided on record to the contrary (which is currently lacking on record; see instant specification, Examples 4, 35-39, in particular).
In addition the limitations of claim 52 for “local cooling of tissues to 55 0F” (i.e. to about 13 degree C; see step (h) of instant claim 52) as presented, would have also been obvious to an artisan in the art as the effects of high temperatures (or heat stress) is known to cause higher production of ROS in living tissues (see Abele et al, 2002, entire Summary). Abele et al disclose the fact that heat stress or increase in tissue temperatures are known to induce production of reactive oxygen species ROS, via mitochondrial respiratory physiology common to cells all living organisms (albeit exemplified using isolated mitochondria from an experimental model, bivalve Mya arenaria whose habitat temperatures normally range from 5 to 15 degree C subjected to heat stress at 20 to 25 degree C; see entire Summary). Thus, local cooling of tissues (being treated in a subject in need with the antioxidant formulation) prior to irradiation and/or peroxide-based dental bleaching procedure (to as low temperature as safely tolerable such as between 15 to 20 degree C depending on the type of subject being treated) would have been obvious and fully contemplated by an artisan of ordinary skill in the art, unless data/evidence provided to the contrary, which is currently lacking on record (see specification dated 02/07/2021, page 34, Example 5, 39, for instances). Therefore, the invention as currently presented fails to distinguish itself over the combined teachings and/or suggestions from the cited prior art references (i.e. Prasad et al taken with disclosure from Bar-Or, Tamas et al, Bhatia et al, and Abele et al), as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Examiner’s Response to Arguments
Applicant's arguments filed on 06/28/2025 regarding the newly presented claims 52-54 have been fully considered but they are not persuasive because of the new grounds of objections/rejections made in this office action as specifically discussed above.
NOTE: Applicant is advised to amend claims accordingly to obviate issues related to claim objections and rejections under 112 and 103(a), as discussed above in order to further the prosecution of this case. Applicant is also advised that additional help to pro-se applicants is available at USPTO website:
https://www.uspto.gov/patents/basics/using-legal-services/pro-se-assistance-program
(Phone: 866-767-3848 -Provides outreach and education for independent inventors who file patent applications without the assistance of a registered patent attorney or agent.)
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached on 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657