DETAILED ACTION
Examiner acknowledges receipt of the reply filed 3/16/2026, in response to the non-final office action mailed 9/17/2025.
Claims 1-5, 7-28, 31-34, 41, and 43-47 are pending. Claims 6, 35-37, 42, and 48 have been cancelled. Claims 2-5, 8, 10, 13-15, 18-26, and 31-33 are withdrawn from further prosecution for the reasons made of record.
Claims 1, 7, 9, 11, 12, 16, 17, 27, 28, 34, 41, and 43-47 are being examined on the merits in this office 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 .
Claim Objections- withdrawn
The objection of claim 1 is withdrawn in view of the amendment filed 3/16/2026.
Claim Rejections - 35 USC § 112
The rejection of claims 1, 6, 7, 9, 11, 12, 16, 17, 27, 28, 34, 35, 37, and 41-48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 3/16/2026.
The rejection of claims 1, 6, 7, 9, 11, 12, 16, 17, 28, 34, 35, 37, and 41-48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 3/16/2026.
Response to Arguments
Applicant’s amendment filed 3/16/2026 with respect to the above rejections have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant's amendment and arguments filed 3/16/2026 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration, a new ground(s) of rejection is made in view of the amendment filed 3/16/2026.
An action on the merits is presented herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
35 USC § 112- maintained, in part
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.
Claim 27 and 28 remains/is 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. This rejection is maintained from the office action mailed 9/17/2025, but has been amended to reflect claims filed 3/16/2026.
The metes and bounds of claim 27 are deemed to be indefinite. Claim 27 recites “wherein the inflammatory disorder of affected skin or mucosa of the patient that is inflamed or contains a wound or burn is associated with oral mucositis, aphthous ulcers, otitis media, laryngitis, tracheitis, esophagitis, gastritis, enteritis, enterocolitis, bacillary dysentery, chronic amoebic dysentery, schistosomiasis, nonspecific ulcerative colitis, regional enteritis, cervicitis, endocervicitis, endometritis, or mucosal inflammation associated with inhalation injury, cancers, or infections”. The recited grouping recites the term “or” twice in the claim. Accordingly, the skilled artisan in not apprised of disorders that fall within and those that fall outside of the claim scope. For example, but not limited to, the last three variables “inhalation injury, cancers, or infections” could be construed as individual components of the larger grouping of recited disorders. Alternatively, “inhalation injury, cancers, or infections” could be construed as a subset related/limited to “mucosal inflammation” associated with inhalation injury, cancers, or infections. It is further not clear that if the underlying cancer or infection is at the mucosal tissues. For instance, it is unclear if the claim scope is intended to encompass e.g. a cancer or infection that occurs elsewhere in the body, e.g., glioblastoma- brain cancer, that can cause e.g., ocular inflammation [reads on mucosa]).
Because claims 28 depends from indefinite claim 27 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Response to Arguments
In the amendment filed 3/16/2026, Applicant amended claim 27 to remove “selected from the group consisting of” and replace “and” with the term “or”. This amendment did not overcome the indefinite rejection.
Please see the above rejection for further details.
New Objections/ Rejections
Claim Objections- New
Claims 1 and 34 are objected to because of the following informalities:
Claim 1 should be amended to recite “as well as a regioisomer a stereoisomer a pharmaceutically- or a cosmetically-acceptable salt
Claim 1 should be amended to remove multiple recitations of “or” and “and/or” in the preamble: A method of treating inflammation of skin or mucosa, an inflammatory disorder of skin or mucosa, and/or a wound or a burn to the skin or mucosa. The metes and bounds of the claim term should clearly presented. Examiner recommends amending to include where appropriate: inserting Roman numerals, (a)..(b), or semicolons.
Claim 34 should be amended to recite “N-terminal Ala, , or a combination thereof”.
Appropriate correction is required.
Claims 7, 11, 12, 16, 41, and 43-47 are objected to as being dependent upon an objected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim 9 and 17 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. This is a new rejection necessitated by the amended filed 3/16/2026.
Claim 9 recites the limitation "the form". There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is deemed to be indefinite. Claim 17 depends from claim 16. Claim 16 recites “wherein the wound to the skin or mucosa is an acute wound or a chronic wound”. Thus claim 16 recites 2 forms of wounds: acute and chronic. Claim 17 recites: “The method as claimed in claim 16, wherein the wound comprises an ulcer of the skin or the mucosa”. It is unclear as to which type of wound [acute or chronic] that claim 17 is referring back it recites “the wound”. Claim clarification is required.
New 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating inflammation of mucosal tissues and inflammation of the skin comprising topical administration of montelukast-peptide conjugates of SEQ ID NOs: 4, 12, 13, 20,22, or 24, e.g. oral mucositis or dermatitis, does not reasonably provide enablement for treating inflammation of internal organs, including but not limited to, gastritis, schistosomiasis, cervicitis, enterocolitis, enteritis, and endometritis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. This is a new rejection necessitated by the amended filed 3/16/2026.
Examiner notes that topical administration is construed as encompassing oral/nasal sprays [e.g., Examples 17, 20, and 26], rectal/anal [Example 43], ocular [Example 42], dermal [e.g., Examples 5, 9, 18, 25, 35, and 41], and pulmonary [lungs] application (Example 38). This has been expanded to reflect pulmonary application.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) The breadth of the claims:
The invention is drawn to a method of treating inflammation of skin or mucosa, an inflammatory disorder of skin or mucosa, and/or a wound or a burn to the skin or mucosa, the method comprising: topically administering to affected skin or mucosa of a patient that is inflamed or contains the wound or burn (i) a peptide-containing compound that comprises: a peptide component comprising the amino acid sequence of SEQ ID NOs: 4, 12, 13, 20, 22, or 24, and at least one of the Ala and/or Lys residues is covalently bonded to one or more compounds of formula I by an amide bond formed by reaction of the carboxylic acid group in formula I and one or more free amino groups in the Ala and/or Lys residues:
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I wherein: the squiggly bond represents cis or trans orientation relative to the carbon-carbon double bond … or (ii) a pharmaceutical formulation comprising said peptide-containing compound, regioisomer, stereoisomer, pharmaceutically- or cosmetically-acceptable salt thereof.
The specification states at paras. [0073]-[0076]:
The “treatment of inflammation” includes the treatment of inflammation in any organ of the body (including soft tissue, joints, nerves, the vascular system, internal organs, especially mucosal surfaces, and particularly the skin), irrespective of the cause, and also includes all such inflammatory disorders or conditions, and/or disorders or conditions characterized by inflammation (e.g. as a symptom).
Inflammatory conditions may be (and are typically) characterized by activation of immune defense mechanisms, resulting in an effect that is more harmful than beneficial to the host. Such conditions are generally associated with varying degrees of tissue redness or hyperemia, swelling, edema, hyperthermia, pain (including aching), exudation of body fluids, itching (pruritis), cell death and tissue destruction, cell proliferation, and/or loss of function.
Inflammatory conditions that may be mentioned include arteritis, diabetes mellitus, metabolic syndrome, rosacea, asthma and allergy, ankylosing spondylitis, chronic obstructive pulmonary disease, gouty arthritis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis), multiple sclerosis, osteoarthritis, pancreatitis…
Inflammatory conditions that may be more especially mentioned include inflammations of the skin or mucosa (including the oral, nasal, ocular, vaginal, cervical and/or anorectal mucosae, more particularly the oral or nasal mucosae), such as inflammation resulting from infections (such as viral and/or bacterial infections), or allergic/atopic conditions (such as rhinitis (e.g. allergic rhinitis), …
[0102] For the avoidance of doubt, in the context of the present invention, the terms "treatment", "therapy" and "therapy method" include the therapeutic, or palliative, treatment of patients in need of, as well as the prophylactic treatment and/or diagnosis of patients which are susceptible to, inflammation and/or inflammatory disorders.
(2) The state of the prior art: the following reflects just a few disorders that falls within the claim scope of “inflammation of skin or mucosa, an inflammatory disorder of skin or mucosa, symptoms of a disorder characterized by inflammation of skin or mucosa, and/or a wound or a burn to the skin or mucosa”.
The Merck manual indicates that there are plethora of inflammatory disorders known, for example, Pelvic Inflammatory Disease, Temporomandibular Disorders, and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), to name just a few (see Merck manual, Inflammatory Disorders enclosed). Additionally, the Merck manual indicates that there are numerous numbers of types of dermatitis, for example, contact dermatitis, stasis dermatitis, perioral dermatitis, atopic dermatitis (Eczema) to name just a few (see Merck manual, Dermatitis enclosed- previously cited). Additionally, the Merck manual indicates that there are plethora of inflammations (see Merck manual, Inflammation enclosed- previously cited).
Inflammation of skin or mucosa can have an underlying genetic cause. Bowcock et al (Human Molecular Genetics 13: R43-R55 (2004)- previously cited) teach that genetic skin disorders include, but are not limited to hyper-IgE syndrome (HIES), Wiskott–Aldrich syndrome, Familial eosinophilia (FE), Netherton’s disease, psoriasis and atopic dermatitis. See Bowcock et al generally.
A search of the art did not uncover a single agent that was able to treat/prevent all infectious diseases (i.e. bacterial, viral, fungal, and parasitic) that fall within the instant claim scope.
There is a great number of bacteria, protozoa and fungal infections. For example, the CDC lists a large number of fungal diseases that cause disease (https://www.cdc.gov/fungal/diseases/index.html accessed 5/21/21- previously cited). The Merck Manual (https://www.merckmanuals.com/home/skin-disorders/fungal-skin-infections/overview-of-fungal-skin-infections accessed 2/19/19) teaches antifungal drugs for treatment of fungal infections. There was no disclosure of treatment for other microorganisms with the antifungal agents. The Merck Manual (https://www.merckmanuals.com/professional/infectious-diseases/fungi/overview-of-fungal-infections accessed 10/21/2020- previously cited) teaches that fungal infections are often classified as either opportunistic or primary. Opportunistic infections are those that develop mainly in immunocompromised hosts; primary infections can develop in immunocompetent hosts.
With respect to bacterial infections, bacterial infections can take on many forms and be caused by Gram-positive and gram-negative bacterium. Doron (International Encyclopedia of Public Health, 2008:273-282- previously cited) teaches that bacteria are ubiquitous and bacterial resistance to antimicrobials is a rapidly growing problem with potentially devastating consequences (Introduction). Doron teaches that new species and new variants of familiar species continue to be discovered, particularly as we intrude into new ecosystems (Introduction). Doron also teaches that host factors are critical in determining whether disease will develop following transmission of a bacteria agent, such as genetic makeup, nutritional status, age, duration of exposure to the organism and coexisting illness (last para of Introduction). Importantly the National Institute of Health (https://www.niaid.nih.gov/research/antimicrobial-resistance-threats 2/11/20- previously cited) teaches that a number of pathogen are increasingly resistant to existing antibiotics and antifungals. For example, the NIH states that N. gonorrheae has developed resistance to nearly all antibiotics used for treatment, making it harder to treat much less prevent.
The Merck Manual (https://www.merckmanuals.com/professional/infectious-diseases/viruses/overview-of-viruses accessed 2/19/19- previously cited) teaches antiviral drugs and states that the drug interfere with viral particle attachment, inhibit cellular receptor, factor required for viral replication or block specific virus coded enzymes. The Merck Manual also teaches that some drugs may be effective against other viruses (i.e. HIV drugs are used for Hepatitis B), however the Merck Manual, nor does the prior art teach that a single drug or drug combination could treat all viruses.
The Merck Manual (https://www.merckmanuals.com/professional/infectious-diseases/approach-to-parasitic-infections/approach-to-parasitic-infections?query=protozoa accessed 10/22/2020- previously cited) teaches that human parasites encompass three different forms: Single-cell organisms (protozoa, microsporidia), multicellular helminths (worms), and ectoparasites such as scabies and lice. Treatments vary depending on the specific form of infection.
Melanoma (Merck Manuals melanoma accessed 1/13/2021 at URL merckmanuals.com/professional/ dermatologic-disorders/cancers-of-the-ski- previously cited) teach that melanoma arises from melanocytes in a pigmented area (e.g., skin, mucous membranes, eyes, or central nervous system). Metastasis is correlated with depth of dermal invasion. With spread, prognosis is poor. Diagnosis is by biopsy. Wide surgical excision is the rule for operable tumors. Metastatic disease requires systemic therapy but is difficult to cure. Melanomas occur mainly on the skin but also on the mucosa of the oral, genital, and rectal regions and conjunctiva. Melanomas may also develop in the choroid layer of the eye, in the leptomeninges (pia or arachnoid mater), and in the nail beds. Melanomas vary in size, shape, and color (usually pigmented) and in their propensity to invade and metastasize. Metastasis occurs via lymphatics and blood vessels. Local metastasis results in the formation of nearby satellite papules or nodules that may or may not be pigmented. Metastasis to skin or internal organs may occur, and, occasionally, metastatic nodules or enlarged lymph nodes are discovered before the primary lesion is identified.
Hypersensitivity and reactive skin disorders (Merck Manual, overview of hypersensitivity and reactive skin disorders, accessed 6/25/2023 at URL merckmanuals.com/home/skin-disorders/hypersensitivity-and-reactive-skin-disorders/overview- previously cited) teach that the immune system plays a vital role in maintaining the health of all the tissues of the body. Some hypersensitivity reactions are called allergies, especially when they occur after exposure to substances that are usually harmless to most people. Hypersensitivity reactions can involve the skin and cause disorders such as the following: drug rashes, erythema multiforme, erythema nodosum, granuloma annulare, keratosis pilaris, Stevens Johnson syndrome, and toxic epidermal necrolysis. Treatment depends on the cause of the disease/disorder.
Psoriasis and scaling diseases (Merck Manual, introduction to psoriasis and scaling diseases, accessed 6/25/2023 at URL merckmanuals.com/home/skin-disorders/psoriasis-and-scaling-disorders- previously cited) teach that psoriasis, parapsoriasis, pityriasis rosea, pityriasis rubra pilaris, lichen planus, and lichen sclerosus are different skin disorders that have been grouped together because the bumps, rashes, scales, and skin discoloration they cause have similar characteristics. That is, the rashes and bumps have well-defined borders, and the scales usually do not crust, crack, or weep with fluid.
Sunlight can also be a causative agent of skin damage leading to sunburn, but also wrinkling and other changes associated with aging, photoaging, actinic keratoses, skin cancers, and even allergic reactions and worsening of some skin diseases (Merck Manual, overview of sunlight and skin damage, accessed 6/25/2022 at URLmerckmanuals.com/home/skin-disorders/sunlight-and-skin-damage- previously cited).
Hair loss, also called alopecia, can occur on any part of the body. Hair loss that occurs on the scalp is generally called baldness. Hair loss is often of great concern to people for cosmetic reasons, but it can also be a sign of a systemic disorder. Common causes of parallels are alopecia areata, chemotherapy, fungal infections, physical or psychological stress, injury, burns and radiation. Alopecia can also have a genetic component (Merck Manual, alopecia, accessed 6/25/2022 at URL merckmanuals.com/home/skin-disorders/hair-disorders) - previously cited.
The art recognizes that there are countless different types of inflammations of skin or mucosa, and/or a wounds or a burns to the skin or mucosa.
(3) The relative skill of those in the art:
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(4) The predictability or unpredictability of the art:
Applicant’s activity is based on the determination of predicting those who are susceptible to ALL inflammation of skin or mucosa, and/or a wound or a burn to the skin or mucosa. Since the activity is based on determining the patient population that is susceptible to disorders, conditions and diseases, the predictability in the art is low. This is due to the fact that the art has recognized that there are plethora of different inflammation of skin or mucosa, and/or a wound or a burn to the skin or mucosa, but does not provide how to determine the individuals who are susceptible to any disorder, condition or disease.
Applicant has not shown who will be susceptible to inflammation of skin or mucosa, and/or a wound or a burn to the skin or mucosa. There are too many variables between the patient populations [further complicated by genetic predispositions], thus, it clearly shows the unpredictability of the art.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. There is no absolute predictability, even in view of the high level of skill in the art.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
The specification provides guidance on how to make specific montelukast-peptide conjugates (Exs 1-4, 32, 33, 36, and 40) and formulations (Exs 12-16). The only peptides of SEQ ID NO:7 reduced to practice were SEQ ID NOs: 4, 12, 13, 20, and 22. Treatments related to various disorders in mouse animal model and human patients (e.g., ear swelling (Exs 5, 9, 35, and 41), acute wound (Ex 6 and 10), rhinitis (Ex 17 and 20), burn patient (Ex 18), dermatitis (ex 25), cold relief (ex 26), lung injury (ex 38), conjunctivitis (ex 42), and ulcerative colitis (Ex 43). All of the examples consisted of topical administration of the montelukast-peptide conjugates. Topical administration is construed as encompassing oral/nasal sprays [e.g., Examples 17, 20, and 26] , rectal/anal [Example 43], ocular [Example 42], dermal [e.g., Examples 5, 9, 18, 25, 35, and 41], and pulmonary applications (Example 38).
The specification has not provided guidance as to the type of inflammation, and/or a wounds or a burns to the skin or mucosa. There is no clear guidance as to the patient population, since not all people suffer from the same disorder, condition or disease, and the amount to treat ALL inflammation of skin or mucosa, and/or a wounds or a burns to the skin or mucosa. Since the art recognizes that there are countless different inflammation and/or a wounds or a burns to the skin or mucosa, but does not provide how to determine the individuals who are susceptible [much less treatment regimens/dosages/etc] to respective disorders, conditions or diseases, more guidance is necessary.
(8) The quantity of experimentation necessary:
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In order to treat a disease, a dosage, the subject and regimen must be identified. In order to ameliorate a disease symptoms or conditions, the end point of the treatment also needs to be identified. It is uncertain to predict the patient population who are susceptible for inflammations of skin or mucosa, and/or a wounds or a burns to the skin or mucosa. Applicant have not provided the appropriate time frame at which the compound should be administered, one of ordinary skill in the art would be burdened with undue “painstaking experimentation study” to determine if the compound would be effective in treating an adult, child, or an infant from all forms of inflammations of skin or mucosa, and/or a wounds or a burns to the skin or mucosa.
Disorders that fall within the instant claim scope also include genetic disorders. There is no guidance in the specification as to how to treat the genetic disease. There is no guidance as to how the skilled artisan could treat other such acute lung injury, blunt force trauma, car accident, third degree burns, etc. Examiner reiterates that these would all fall within the instant claim scope.
It is further noted that the specification is limited to topical administration of specific montelukast-peptide conjugates (SEQ ID NOs: 4, 12, 13, 20, and 22) for treatment of specific forms of mucosal tissue inflammation disorders, and inflammation of the skin.
The claims include, but are not limited to, infection (bacteria, virus, fungal, etc), cancer, alopecia, acute lung injury, wounds/burns, etc. The claim scope is construed as treating the underlying disease/disorder – infection- treat the bacteria, fungus (e.g., candida or yeast), viral (Covid, chicken pox/Varicella), cancer- unregulated cell growth, etc. The claim scope of instant claims 27 and 28 encompasses inflammation of internal organs, e.g., including but not limited to, gastritis and endometritis. The instant claims are drawn to topical administration. There is no support or guidance that the claimed peptide-containing compound can be effectively administered to treat inflammation of internal organs. Applicant has not shown that they are enabled for the full scope of the instant claims.
Closest Prior Art
Reed et al. (U.S. 2009/0186038- previously cited) teach prophylactic an therapeutic protocols designed to prevent, manage, treat, or ameliorate a respiratory condition or one or more symptoms thereof. In particular, the present invention provides methods for preventing, managing, treating, or ameliorating a respiratory condition or one or symptoms caused by environmental factors or a respiratory infection. The present invention encompasses combination therapies, pharmaceutical compositions, articles of manufacture, and kits (abstract). Regarding claim 1, in a specific embodiment, the IL-9 antagonist (e.g., an antibody that is an IL-9 antagonist) is conjugated to a leukotriene antagonist (e.g., montelukast, zafirlukast, pranlukast, and zyleuton). Montelukast is a compound wherein R1 is -C(CH3)2OH and n is 0. The reference does not teach or suggest a peptide containing compound comprising SEQ ID NO:7 covalently bonded to formula I (montelukast).
Instant SEQ ID NO:4 has 97.3% identity with amino acids 491-500 of UniProtKB accession number Q27409- previously cited, an adhesive plaque matrix protein from Mytilus galloprovincialis (Mediterranean mussel).
Instant SEQ ID NO:12 has 95.5% identity with amino acids 547-556 of UniProtKB accession number Q25460 - previously cited, an adhesive plaque matrix protein from Mytilus edulis.
Instant SEQ ID NO:13 has 95.5% identity with amino acids 209-218 of UniProtKB accession number Q25460 - previously cited, an adhesive plaque matrix protein from Mytilus edulis.
Instant SEQ ID NO:20 has 88.6% identity with amino acids 491-498 of UniProtKB accession number Q27409- previously cited, an adhesive plaque matrix protein from Mytilus galloprovincialis (Mediterranean mussel).
Instant SEQ ID NO:22 has 86.5% identity with amino acids 491-500 of UniProtKB accession number Q27409- previously cited, an adhesive plaque matrix protein from Mytilus galloprovincialis (Mediterranean mussel).
Instant SEQ ID NO:24 has 79.5% identity with amino acids 128-134 of UniProtKB accession number Q97JU2 – previously cited, a phage related protein from the bacterium Clostridium acetobutylicum.
Conclusion
No claims are allowed.
Claims 1-5, 7-28, 31-34, 41, and 43-47 are pending. Claims 2-5, 8, 10, 13-15, 18-26, and 31-33 are withdrawn.
Claims 9, 17, 27, and 28 are rejected.
Claims 1, 7, 11, 12, 16, 34, 41, and 43-47 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654
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