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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 01/15/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous 35 U.S.C. 103 rejections for obviousness have been withdrawn necessitated by Applicant’s amendments.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 20 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated, or in the alternative, under 35 U.S.C. 103 as being unpatentable over Starley (The treatment of paediatric burns using topical papaya; 1999 – previously cited).
Starley’s general disclosure relates to the preparation of Carica papaya in burn dressings, wherein Carica papaya is “effective in desloughing necrotic tissue, preventing burn wound infection, and providing a granulating wound suitable for the application of split thickness skin graft” (see, e.g., Starley, abstract). Moreover, Starley discloses that the ability for Carica papaya to perform these activities in burn dressings is due to the activity of proteolytic enzymes chymopapain, and papain, as well as an antimicrobial activity (see, e.g., Starley, abstract). Furthermore, Starley discloses that the desloughing effect exhibited by Carica papaya “may be related to proteolytic enzymes. Papaya contains papain, leukopapain, and chymopapain” (see, e.g., Starley, “Section 3. Comment”, pg. 639), and that “The dynamics of leucopapaine in wound healing, using both animal models and clinical setting, have suggested that it is effective in facilitating would cleaning primarily as a desloughing agent, promoting growth and improving the quality of the scar” (see, e.g., Starley, “Section 3. Comment”, g. 639). Furthermore, Starley discloses that “Papaya also contains carpaine and aglycones which have broad spectrum antimicrobial activity” (see, e.g., Starley, “Section 3. Comment”, g. 639).
Regarding claims 20 and 22-23 pertaining to administering proteolytically active serine proteases from Carica papaya to a subject in need thereof, Starley teaches treating infected or full thickness burns on children with topical papaya paste (see, e.g., Starley, “Section 2. Method”, pg. 637), wherein the papaya is used for desloughing of wounds, wound healing, and antimicrobial activity (see, e.g., Starley, “Section 3. Comment”, g. 639). Furthermore, Starley teaches “Infected or full thickness burns are treated with topical papaya paste. We find the simplest method to apply the papaya to the burn is to spread the papaya paste on gauze and then apply the gauze to the wound (Fig. 4). Papaya applied by this method is sufficient for the dressing to stick to the wound and has the advantage of avoiding circumferential dressings, which are uncomfortable in a tropical environment. As the papaya dressing has usually dried by the following day it is usually necessary to soak the dressing off with water. Typically, the papaya paste is applied once a day, but occasionally as twice daily dressings for infected wounds (Fig. 5) or wounds with thick eschars” (see, e.g., Starley, “Section 2. Method”, pgs. 637-638). Moreover, as it pertains to prepping the papaya for administration, Starley teaches removal of the skin and seeds of the papaya, followed by mashing the papaya into a paste (see, e.g., Starley, Section 2. Method, pg. 637). Therefore, applying papaya paste directly to burns, as taught by Starley, inherently results in applying proteolytically active serine proteases from papaya to subjects in need thereof since Carica papaya inherently contains proteolytically active serine proteases, such as papaya subtilase, CpSUB1, which is present in ripened and unripened papaya flesh (see, e.g., Art of Record, Othman – previously cited).
Regarding claim 20 and 22-23’s recitation of “…extracted from ripe fruit of Carica papaya…” and recitation of “wherein the composition is prepared by a process comprising treating pulped ripe fruit of Carica papaya with an alkali, without subjecting the pulped ripe fruit to a heating step, and separating soluble protease from insoluble plant material after the alkali treatment”, these are considered a product-by-process limitations; therefore, patentability is based on the product itself and does not depend on its method of production (see, e.g., MPEP 2113(I)).
The disclosure of Starley teaches administration of papaya paste directly to burns, wherein the papaya paste inherently contains active serine proteases, such as CpSUB1 (see, e.g., Starley, “Section 2. Method”, pgs. 637-638 & Othman – Art of Record). Regarding the recitation of “wherein the composition is prepared by a process comprising treating pulped ripe fruit of Carica papaya with an alkali, without subjecting the pulped ripe fruit to a heating step, and separating soluble protease from insoluble plant material after the alkali treatment”, this is a product-by-process limitation. Starley teaches removal of the skin and seeds of the papaya, followed by mashing the papaya into a paste (see, e.g., Starley, Section 2. Method, pg. 637). Since the claims are directed to product by process limitations, the removal of the seeds and skin read on the wherein clause. Mashing the papaya fruit would inherently result in production and subsequent administration of papaya, which contains active serine proteases without the fibrous material. Furthermore, Starley does not teach heating of the papaya paste. Moreover, the lack of physical description of the product (i.e., proteolytically active serine proteases) results in difficulty determining if the product-by-process limitations (i.e., alkali treatment and lack of heating steps) result in structural limitations (see, e.g., MPEP 2113). Further, Starley teaches applying papaya juice to treat warts, corns, and cancers (see, e.g., Starley, Section 3. Comment, pg. 639)which reads on the wherein clause since the fibrous material is removed and applied to a subject in need of.
Therefore, administered product (i.e., proteolytically active serine proteases) taught by Starley appears to be identical to the instantly claimed invention and therefore anticipated.
In the alternative, if the product by process limitations impart a structural limitation, the claims are rendered obviousness since Starley teaches a method of treating burn wounds on patients by administration of topical papaya paste, which inherently contains active serine proteases; therefore, any minor changes to the composition are rendered obvious since the prior art does not heat the enzymes or use an alkali. As discussed above, Starley teaches applying papaya juice to treat warts, corns, and cancers (see, e.g., Starley, Section 3. Comment, pg. 639); therefore, the papaya juice does not contain fibrous material and is not heated. Therefore, it is obvious that lack of heating or use of an alkali results in a proteolytically active serine protease because there are no steps that would result in inactivation of the serine protease’s activity. Moreover, since the serine protease inherently contained within the papaya is active, it would be obvious to apply the papaya to treat skin conditions, based on the teaching of Starley.
This, the claimed invention, as a whole, was clearly prima facie obvious especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Examiner’s Response to Arguments
Applicant’s arguments filed 01/15/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments pertaining to Starley providing no information as to the ripeness of the papaya (remarks, page 7), this argument is not persuasive because, as discussed above, Starley teaches applying papaya flesh paste directly to burn wounds, and papaya flesh, from both ripened and unripened papaya, inherently express proteolytically active serine proteases, as evidenced by Othman. Furthermore, as discussed above, recitation of “…extracted from ripe fruit of Carica papaya…” is a product-by-process limitation; therefore, patentability is based on the composition (i.e., one or more proteolytically active serine proteases), and not the method of production (i.e., obtaining the proteolytically active serine proteases from ripe fruit of Carica papaya).
Regarding Applicant’s arguments pertaining to Starley and Othman not demonstrating that the serine protease is proteolytically active (remarks, pages 7-8), this argument is not persuasive because Starley teaches that the Carica papaya is mashed and applied to wounds; therefore, the serine proteases inherently present in the papaya flesh would be active because there is no heating step that would result in the serine proteases becoming inactivated. Furthermore, Othman, which is now art of record, teaches that papaya subtilase, CpSUB1, which is a serine protease, is inherently present in unripened and ripened papaya flesh, with maximum expression at 25% ripening stage (see, e.g., Othman, “Organ specificity and expression patterns of CpSUB1 gene”, pg. 134). Furthermore, Othman teaches that papaya was harvested at 5%, 25%, 50%, 75%, and 100% ripeness (see, e.g., Othman, “Plant materials and partial subtilisin sequence”, pg. 132) and further showed that papaya subtilase, CpSUB1, is present at 100% ripeness (see, e.g., Othman, Figure 4). Moreover, Othman teaches “The expression of subtilase protein commenced at mature green until 100% ripening stage” (see, e.g., Othman, “Detection of subtilase protein during ripening”, pg. 135), therefore, this serine protease is present in ripened and unripened papaya. Furthermore, Othman teaches “RNA and protein gel blot analysis indicate that the papaya subtilase may be involved in papaya fruit ripening” (see, e.g., Othman, Discussion, pg. 136). Additionally, Othman teaches “Hence, this mesocarp-specific subtilase (Fig. 4B) may play a role in the early stage of fruit development and ripening by degrading cell wall matrix” (see, e.g., Othman, Discussion, pg. 136). Therefore, based on the teachings of Othman, the papaya subtilase appears to be proteolytically active due to its ability to aid in the ripening process and degrade cell wall matrix (see, e.g., Othman, Discussion, pg. 136). Therefore, papaya subtilase, CpSUB1, is a proteolytically active serine protease derived from ripened and unripened papaya flesh. Moreover, as discussed above, based on the supportive teaching of Othman showing that CpSUB1 is inherently present in ripened and unripened papaya fruit, merely applying papaya fruit directly to a skin condition, as taught by Starley, would inherently result in application or administration of a proteolytically active serine protease since the serine protease is present in the papaya fruit. Additionally, as discussed above, Starley does not teach heating the papaya fruit; therefore, the activity of the serine proteases inherently present in the papaya fruit are maintained.
Regarding Applicant’s arguments pertaining to the present claims and their amendments (remarks, page 8), as discussed above, the recitation of “wherein the composition is prepared by a process comprising treating pulped ripe fruit of Carica papaya with an alkali, without subjecting the pulped ripe fruit to a heating step, and separating soluble protease from insoluble plant material after the alkali treatment” is considered a product-by-process limitation; therefore, patentability is based on the product itself (i.e., proteolytically active serine proteases), and not the method of production. As discussed above, the lack of physical description in the claimed product-by-process limitation makes determination of the patentability more difficult (see, e.g., MPEP 2113). Furthermore, MPEP 2113 states “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).” Starley teaches removal of the skin and seeds of the papaya, followed by mashing the papaya into a paste (see, e.g., Starley, Section 2. Method, pg. 637). Mashing the papaya fruit would inherently result in production and subsequent administration of papaya juice, which contains active serine proteases without the fibrous material. Furthermore, Starley does not teach heating of the papaya paste. Therefore, the claimed invention appears to be anticipated by Starley. However, if the product-by-process limitation does indeed impart some structural limitation, such as with the alkali treatment and lack of heating, these processes, or lack thereof, would have been prima facie obvious to one of ordinary skill in the art because these steps would result in extraction of the proteolytically active serine proteases from the fruit, wherein the serine proteases maintain their activity upon extraction because there is not heating step.
Art of Record
Othman R, Nuraziyan A. Fruit-specific expression of papaya subtilase gene. J Plant Physiol. 2010 Jan 15;167(2):131-7. doi: 10.1016/j.jplph.2009.07.015. PMID: 19729222.
Conclusion
Claims 20 and 22-23 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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