DETAILED ACTION
Second Notice to Pro Se Applicant
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Response to Amendment
Examiner acknowledges the reply filed 02/06/2026. Claims 17, 33 and 34 were amended. Claims 1-16 and 18-32 are canceled. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
Election/Restrictions
Newly amended claim 34 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 34 has been amended to recite a composition not suspended in a pharmaceutical carrier, which is independent and distinct from the originally presented invention (a composition suspended in a pharmaceutical carrier).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 34 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
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 17, 34 and any claim depending therefrom, is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 17, the following claim limitations recite new matter, and are followed by reasons for the finding of new matter:
"…an aqueous solution of zinc chloride or zinc hydrochloride mixed with immunologic and pharmacologic anti- cancer compounds and hemostatic agents…"
The original specification does not disclose this feature.
"…immediately destroy malignant cells and stop bleeding…"
The original specification does not disclose this feature.
"blending and combining a bacterial derived nanofibrillar drug-releasing polysaccharide cellulose with viscoelastic biopolymeric polysaccharides, inert gum fillers, binders and thickeners, resulting in an expandable elastic compressible synthetic moldable gum matrix"
The original specification does not disclose blending or combining a bacterial derived nanofibrillar drug-releasing polysaccharide cellulose with viscoelastic biopolymeric polysaccharides, inert gum fillers, binders and thickeners, resulting in an expandable elastic compressible synthetic moldable gum matrix, or combining a bacterial derived nanofibrillar drug-releasing polysaccharide.
"…wherein the said composition is capable of treating other cancerous tumors, including a breast tumor, bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands…"
The original specification does not disclose that the composition itself is capable of treating any or all of these tumors.
“…the dose-specific concentration of zinc chloride or zinc hydrochloride in the composition is between 0.0001% and 50%..."
The original specification does not disclose the concentration as low as .0001%.
"…the adhered synthetic gum matrix is capable of rapidly releasing the zinc chloride or zinc hydrochloride medicated mixture into cancerous tissues upon compression immediately following surgery.."
The specification makes no mention of "immediately".
Regarding claim 34, the following claim limitations recite new matter, and are followed by reasons for the finding of new matter:
“…the dose-specific concentration of zinc chloride or zinc hydrochloride in the composition is between 0.0001% and 50%, optimizing in a concentration of 0.0001% to 20% by weight…".
The original specification does not disclose the concentration as low as .0001%.
"…said composition is perfused over inaccessible tumors and post-operative cancer surgical wounds and compressed into the wounds with sterile gloved hand, sterile cotton gauze, sterile cotton tipped applicators of different sizes and shapes or balloon compressed, wherein the said composition is perfused over a post-operative cancer surgical wound in the vesicle of an organ such as the urinary bladder, with a high propensity to form new cancerous tumors in the lining of said vesicular organ…"
The original specification does not disclose perfusion.
"…formulated for repeated intravesical administration into an organ such as the urinary bladder to treat existing tumors and to prevent further tumor formation in the lining of said urinary bladder…"
The original specification does not disclose repeated intravesical administration.
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 17 and 33 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.
Regarding claim 17, the following claim limitations are indefinite, and are followed by reasons for lack of definiteness:
"…a composition comprising an aqueous solution of zinc chloride or zinc hydrochloride mixed with immunologic and pharmacologic anti- cancer compounds and hemostatic agents, such as amylopectin, or a pharmaceutical carrier in which said aqueous composition is suspended, for local drug release into cancerous tumors and/or post- operative cancerous tissues to immediately destroy malignant cells and stop bleeding…"
Due to "compounds" and "agents" being in plural form, a skilled artisan may interpret this to mean that the aqueous solution must be mixed with multiple immunologic and pharmacologic anti-cancer compounds as well as multiple hemostatic agents at the same time. However, from the claim it is not clear if this was Applicant's intention. For the purpose of examination, the limitation will be interpreted to mean " an aqueous solution… mixed with one or more immunologic compounds, pharmacologic anti-cancer compounds and hemostatic agents".
"…such as amylopectin…"
The claim does not limit the claim to amylopectin because it refers to an optional compound or agent. However, it is not clear if Applicant intended to positively recite amylopectin. For the purpose of examination, amylopectin will be interpreted to be an optional feature.
"…immediately destroy malignant cells and stop bleeding…"
The term "immediately" is relative. A skilled artisan, when reading the specification, would not know the metes and bounds of the term "immediately", i.e., would not know whether "immediately" refers to a specific time period (such as within a certain number of seconds, minutes or hours) or a non-specific general time period. For the purpose of examination, the limitation will be interpreted to mean "destroy malignant cells and stop bleeding".
"…wherein the gum formulation is placed and compressed into a post- operative surgical wound, such as a lumpectomy for breast cancer, to release the said composition…"
The limitation requires that the gum formulation be placed and compressed into a post-operative surgical wound, whereas the claim is recited only as a kit, and not as a method for use. For the purpose of examination, the limitation will be interpreted to mean "wherein the gum formulation is able to be placed and compressed into a post- operative surgical wound, such as a lumpectomy for breast cancer, to release the said composition".
"…the said composition is capable of treating other cancerous tumors, including a breast tumor, bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands…"
The limitation is not clear as to whether the composition is capable of treating all of the tumors listed. For the purpose of examination, the limitation will be interpreted to mean "the said composition is capable of treating one or more tumors selected from the group consisting of a tumor, including a cancerous tumor, a breast tumor, a bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands…".
"…optimizing a concentration of 10% to 30% by weight in the pharmaceutical carrier."
The meaning of "optimizing" is unclear. For the purpose of examination, the limitation will be interpreted to mean "optionally a concentration of 10% to 30% by weight in the pharmaceutical carrier."
Regarding claim 33, the following claim limitations are indefinite, and are followed by reasons for lack of definiteness:
"…wherein the balloon compressor manufactured in different sizes and shapes and designed and dimensioned to fit in a post-operative cancer surgical wound…"
The claim should be written to recite a specific size or shape; the inclusion of "different sizes or shapes" implies that multiple sizes and shapes are being claimed. For the purpose of examination, the limitation will be interpreted to mean "…wherein the balloon compressor manufactured, designed and dimensioned to fit in a post-operative cancer surgical wound…".
"…comprises a non-medicated expandable membrane or a medicated expandable membrane, wherein the medicated expandable membrane is coated and adhered with the said expandable synthetic gum matrix containing the zinc chloride or zinc hydrochloride medicated mixture, and wherein the balloon includes a cannula to fill such balloon with liquid or gas, to expand and conform the medicated balloon membrane to the walls of the cancerous cavity and the adhered synthetic gum matrix is capable of rapidly releasing the zinc chloride or zinc hydrochloride medicated mixture into cancerous tissues upon compression immediately following surgery.
It is unclear what features are intended to be a part of the medicated expandable membrane and what features are intended to be a part of the non-medicated expandable membrane.
The claim recites features of an unrequired element (i.e., the medicated expandable membrane", which is not required to be present as a "non-medicated membrane" could be used instead). For the purpose of examination, the limitation will be interpreted to mean "…comprises a non-medicated expandable membrane or a medicated expandable membrane, wherein if the expandable membrane is medicated, it is coated and adhered with the said expandable synthetic gum matrix containing the zinc chloride or zinc hydrochloride medicated mixture…"
"…the cancerous cavity…"
This limitation lacks antecedent basis. For the purpose of examination, the limitation will be interpreted to mean "…a cancerous cavity…".
Regarding claim 34, the following claim limitations are indefinite, and are followed by reasons for lack of definiteness:
"…a composition comprising an aqueous solution of zinc chloride or zinc hydrochloride mixed with immunologic and pharmacologic anti- cancer compounds and hemostatic agents, such as amylopectin, or a pharmaceutical carrier in which said aqueous composition is suspended, for local drug release into cancerous tumors and/or post- operative cancerous tissues to immediately destroy malignant cells and stop bleeding…"
Due to "compounds" and "agents" being in plural form, a skilled artisan may interpret this to mean that the aqueous solution must be mixed with multiple immunologic and pharmacologic anti-cancer compounds as well as multiple hemostatic agents. However, from the claim it is not clear if this was Applicant's intention. For the purpose of examination, the limitation will be interpreted to mean " an aqueous solution… mixed with one or more immunologic and pharmacologic anti-cancer compounds and hemostatic agents".
"…said composition is perfused over inaccessible tumors and post-operative cancer surgical wounds and compressed into the wounds with sterile gloved hand, sterile cotton gauze, sterile cotton tipped applicators of different sizes and shapes or balloon compressed, wherein the said composition is perfused over a post-operative cancer surgical wound in the vesicle of an organ such as the urinary bladder, with a high propensity to form new cancerous tumors in the lining of said vesicular organ…"
The claim is recited only as a kit, and not as a method for use. For the purpose of examination, the limitation will be interpreted to mean "said composition is able to be perfused over inaccessible tumors and post-operative cancer surgical wounds and compressed into the wounds with sterile gloved hand, sterile cotton gauze, sterile cotton tipped applicators of different sizes and shapes or balloon compressed, wherein the said composition is capable of being perfused over a post-operative cancer surgical wound in the vesicle of an organ such as the urinary bladder, with a high propensity to form new cancerous tumors in the lining of said vesicular organ…"
"…the aqueous solution of zinc chloride or zinc hydrochloride mixed with immunologic and pharmacologic active anti-cancer compounds…"
Due to "compounds" being in plural form, a skilled artisan may interpret this to mean that the aqueous solution must be mixed with multiple immunologic and pharmacologic anti-cancer compounds. However, from the claim it is not clear if this was Applicant's intention. For the purpose of examination, the limitation will be interpreted to mean "the aqueous solution of zinc chloride or zinc hydrochloride mixed with one or more immunologic and pharmacologic active anti-cancer compounds…"
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.
Claim 34 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brooks et al (U.S. Pub. 2002/0150630 A1, hereinafter “Brooks”).
Regarding claim 34, Brooks discloses a kit comprising:
an article of manufacture, comprising:
a package (2, 2’, 2’’ and/or 2’’’ in Figs. 1A-1C or packages 10-16 in Figs. 5-11) designed to store a unit dose of a medication (see pad 8 “impregnated with a dose specific quantity of zinc chloride mixture 22”; see para [0079]),
a composition (the dose specific quantity of zinc chloride mixture 22 itself) comprising an aqueous solution of zinc chloride or zinc hydrochloride not suspended in a pharmaceutical carrier (see para [0023] disclosing the zinc chloride mixture dissolved in an inert matrix such as cellulose)
used for inaccessible cancerous tumors and/or post-operative cancerous tissues to destroy malignant cells and stop bleeding (this limitation is recited functionally, and the device of Brooks is capable of this function since the zinc chloride can be mixed with immunologic agents [Imiquimod, Interferon, Interleukin 2, and Melanoma Vaccine]) and pharmacologic anti-cancer compounds [5-fluorouracil, imiquimod, podophyllum, paclitaxel, BCNU, DTIC, Cisplatinum, Tamoxifen, Vinblastine, Bleomycin, Interferon, Interleukin 2, and Melanoma Vaccine] and hemostatic agents [aluminum chloride]),
wherein the dose-specific concentration of zinc chloride or zinc hydrochloride in the composition is between 0.0001% and 50%, optionally of .0001-20% by weight (see para [0027] disclosing a preferred mixture of 45% zinc chloride concentration by weight).
wherein the said composition is capable of treating other cancerous tumors, including a breast tumor, bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands (see para [0076], disclosing a variety of anti-cancer agents used in the treatment of cancers described above)
wherein the dose-specific concentration of zinc chloride or zinc hydrochloride in the composition is between 0.1% and 50%, optionally of 10-30% by weight (see para [0027] disclosing a preferred mixture of 45% zinc chloride concentration by weight),
wherein the aqueous solution of zinc chloride or zinc hydrochloride mixed with immunologic and pharmacologic active anti-cancer compounds is formulated for repeated intravesical administration into an organ such as the urinary bladder to treat existing tumors and to prevent further tumor formation in the lining of said urinary bladder, wherein the inaccessible tumors include a breast tumor, bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands (see para [0076], disclosing a variety of anti-cancer agents used in the treatment of cancers described above).
The limitation "the said composition is perfused over inaccessible tumors and post-operative cancer surgical wounds and compressed into the wounds with sterile gloved hand, sterile cotton gauze, sterile cotton tipped applicators of different sizes and shapes or balloon compressed, wherein the said composition is perfused over a post-operative cancer surgical wound in the vesicle of an organ such as the urinary bladder, with a high propensity to form new cancerous tumors in the lining of said vesicular organ…" recite functional language.
Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Therefore, if the prior art discloses a device that can inherently perform the claimed function, a rejection under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate. See In re Translogic Technology, Inc., 504 F.3d 1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir. 2007). See also Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), holding that “apparatus claims cover what a device is, not what a device does”.
In this case, the prior art apparatus of Brooks, in view of Badshah, teaches all the structural limitations of the claim. The limitations do not appear to impart a structural limitation to the composition.
Claim Rejections - 35 USC § 103
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.
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 17 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Brooks et al (U.S. Pub. 2002/0150630 A1, hereinafter “Brooks”) in view of Badshah (“Surface modification and evaluation of bacterial cellulose for drug delivery”, 2018, hereinafter “Badshah”).
Regarding claim 17, Brooks discloses a kit comprising:
an article of manufacture, comprising:
a package (2, 2’, 2’’ and/or 2’’’ in Figs. 1A-1C or packages 10-16 in Figs. 5-11) designed to store a unit dose of a medication (see pad 8 “impregnated with a dose specific quantity of zinc chloride mixture 22”; see para [0079]),
a composition (the dose specific quantity of zinc chloride mixture 22 itself) comprising an aqueous solution of zinc chloride or zinc hydrochloride dissolved or suspended in a pharmaceutical carrier (see para [0023] disclosing the zinc chloride mixture dissolved in an inert matrix such as cellulose) mixed with immunologic agents (Imiquimod, Interferon, Interleukin 2, and Melanoma Vaccine; see para [0076]) and pharmacologic anti- cancer compounds (5-fluorouracil, imiquimod, podophyllum, paclitaxel, BCNU, DTIC, Cisplatinum, Tamoxifen, Vinblastine, Bleomycin, Interferon, Interleukin 2, and Melanoma Vaccine; see para [0076]) and hemostatic agents (aluminum chloride; see para [0093]),
for local drug release into cancerous tumors and/or post- operative cancerous tissues to immediately destroy malignant cells and stop bleeding (this limitation is recited functionally, and the device of Brooks is capable of this function; see below for an explanation of functional language),
wherein the pharmaceutical carrier comprises a gum formulation (Brooks discloses that the pharmaceutical carrier can comprise xanthan gum);
wherein the gum formulation is capable of being placed and compressed into a post-operative surgical wound, such as a lumpectomy for breast cancer, to release the said composition (this limitation is recited functionally, and the device of Brooks is capable of this function; see below for an explanation of functional language),
wherein the said composition is capable of treating other cancerous tumors, including a breast tumor, bladder tumor, a uterine tumor, a vaginal tumor, a cervix tumor, an anal or rectal tumor, an esophageal tumor, a prostate tumor, a pancreatic tumor, and a head and neck tumor including a tumor of the mouth, the accessory nasal sinuses, the larynx, the parotid glands, and other salivary glands (see para [0076], disclosing a variety of anti-cancer agents used in the treatment of cancers described above)
wherein the dose-specific concentration of zinc chloride or zinc hydrochloride in the composition is between 0.1% and 50%, optionally of 10-30% by weight (see para [0027] disclosing a preferred mixture of 45% zinc chloride concentration by weight).
It is noted that Brooks does not appear to disclose that the pharmaceutical carrier comprises a gum formulation prepared by blending and combining a bacterial derived nanofibrillar drug-releasing polysaccharide cellulose with viscoelastic biopolymeric polysaccharides, inert gum fillers, binders and thickeners, resulting in an expandable elastic compressible synthetic moldable gum matrix.
Brooks discloses that the composition further comprises one or more inert paste or matrix fillers, thickeners, and binders chosen from titanium dioxide (see para [0076]), turmeric (see para [0076]) or galangal (para [0076]).
Further, Badshah discloses that bacterial derived moldable cellulose gum can be suitable carriers for drugs (see Introduction). Badshah discloses an experimental bacterial derived moldable cellulose gum that has been loaded with a drug (see section 2.2) and teaches that after evaluation, it was concluded that the bacterial derived moldable cellulose gum had “the potential for applications in drug delivery system, particularly prolonged and controlled drug delivery” (see section 4).The gum is interpreted to be viscoelastic and compressible. Applicant admits that the bacterial cellulose in the Badshah report is non-toxic, biodegradable, simple to produce and purify, forms into a nanofibrillar moldable network gum structure in which zinc chloride can be suspended and is an effective drug delivery system (see Applicant specification at pg. 5).
A skilled artisan would have found it obvious at the time of the invention to modify the pharmaceutically active carrier of the invention of Brooks to comprise the claimed gum formulation, based on the teaching in Brooks that the composition further comprises one or more inert paste or matrix fillers, thickeners, and binders, and the teaching in Badshah that its gum formulation was found to be a suitable carrier for drugs, in particular, a carrier for drugs intended to be delivered over a prolonged duration or in a controlled manner, with a reasonable expectation of success. Choosing this combination of compositional features for the carrier would have been within the level of ordinary creativity, and would have been expected to perform similarly, or better than xanthan gum, based on the bacterial derived moldable cellulose gum’s ability to delivered drugs over a prolonged duration or in a controlled manner.
The limitations "for local drug release into cancerous tumors and/or post- operative cancerous tissues to immediately destroy malignant cells and stop bleeding" and "wherein the gum formulation is capable of being placed and compressed into a post- operative surgical wound, such as a lumpectomy for breast cancer, to release the said composition…" recite functional language.
Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Therefore, if the prior art discloses a device that can inherently perform the claimed function, a rejection under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate. See In re Translogic Technology, Inc., 504 F.3d 1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir. 2007). See also Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), holding that “apparatus claims cover what a device is, not what a device does”.
In this case, the prior art apparatus of Brooks, in view of Badshah, teaches all the structural limitations of the claim. The limitation that the article is "for local drug release into cancerous tumors and/or post- operative cancerous tissues to immediately destroy malignant cells and stop bleeding" and the gum formulation is "capable of being placed and compressed into a post- operative surgical wound, such as a lumpectomy for breast cancer, to release the said composition… “ does not appear to impart a structural limitation to the gum (even so, paras [0029] and [0098] of Brooks discloses use of the device in or on a wound).
Regarding claim 33, it is noted that the claim is recited nearly entirely as functional language of the synthetic gum matrix pharmaceutical carrier already recited in claim 17. Specifically, claim 33 recites that the carrier be "capable of balloon compression" and goes onto recite features of a balloon compressor and a medicated expandable membrane that are not positively recited structural features of the claimed invention.
Response to Arguments
Applicant’s arguments (see Remarks dated 02/06/2025) with respect to the pending claims have been considered.
Applicant's response to the rejection of claims 19, 20, 21 and 26, under 35 U.S.C. 112(a) have been considered, but are moot in view of the cancelation of claims 19, 20, 21 and 26.
Applicant's response to the rejections of claims 33 and 34, under 35 U.S.C. 112(a) have been considered, but are moot in view of the amendment to claims 33 and 34.
Applicant's response to the rejections of claims 17, 19-21, 26 and 34 under 35 U.S.C. 103 have been considered, but are moot in view of the amendment to claims 17, 19-21, 26 and 34. The new ground of rejection, necessitated by the amendment, is explained above.
Applicant's response to the rejection of claim 18, under 35 U.S.C. 103, has, been considered, but are moot in view of the cancelation of claim 18.
Applicant's response to the rejection of claim 33, under 35 U.S.C. 103, has been considered, but is not persuasive because the claim does not, in fact, require the structure of a balloon compressor. Rather, the claim recites "a synthetic gum matrix pharmaceutical carrier capable of balloon compression" and then goes on to recite certain features of the balloon compressor; these balloon compressor features do not convey structure to the synthetic gum matrix pharmaceutical carrier.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ramsey et al (U.S. Pat. 10,918,838 B2; previously cited) discloses a kit comprising a balloon compressor designed to compress a wound, comprising a synthetic impermeable nonmedicated expandable membrane (such as polyurethane; see col. 29, lines 5-7; and see also lines 15-17 disclosing that the balloon is “not constructed of a porous material”), and also including a cannula configured to fill the balloon with a liquid or gas (see col. 26, lines 30-40; and see col. 16, lines 45-47 disclosing the inflation media).
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
03/11/2026